Carrières

Carrières

Chez BVI Medical, nous sommes toujours à la recherche de professionnels engagés, novateurs et talentueux, désireux de faire progresser leur carrière dans le secteur de l’ophtalmologie. Nous recherchons des personnes désireuses de constamment apprendre, collaborer et faire progresser la santé dans le monde entier.  Les employés de BVI Medical bénéficient d’un ensemble complet d’avantages sociaux et d’un salaire compétitif à la mesure de leur valeur. Les prestations sont discutées individuellement au moment du recrutement.

BVI Medical est un employeur qui souscrit aux principes de l’égalité des chances et de l’action positive (lien). Tous les candidats qualifiés seront considérés pour un emploi sans égard à l’appartenance ethnique, la couleur, la religion, le sexe, l’origine nationale, l’invalidité ou le statut d’ancien combattant protégé.

Sr Application Developer

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Sr. Application Developer As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

The Sr. Application Developer Manages support, design and development initiatives for the rollout of Salesforce, Salesforce CPQ, HRIS and LMS systems.Identify areas/potential projects where process redesign/improvement can significantly impact efficiency, quality, profitability, competitive position and customer experience; work closely with Business Partners to ensure that process improvement projects support the strategic priorities of the organization; teach process improvement classes and coach process improvement practitioners across the company. Seeks out and champions new business and technology initiatives with company stakeholders.

Responsibilities

Provides clear leadership and support of Salesforce, HRIS and LMS deployed systems consistent with the objectives of fulfilling BVI’s’s vision, mission, policies and procedures. Direct efforts toward high-value results. Set goals and objectives. Ensure that 3rd party development organizations comply with BVI standards and procedures; Responsible for the design,development and maintenance of Salesforce, Salesforce CPQ, Sage HRIS and LMS systems; Work closely with Business and IT staff in BVI Regional and Global IT organizations. Coordinate Plant and Business activities, implement Regional and Global initiatives for globally deployed Business Systems; Ensure that BVI Waltham globally deployed Systems are in compliance with BVI corporate directives, FDA regulations, and ISO standards; Responsible for creating and managing project budget. Will create capital requests as needed.

Qualifications

3+ years of Salesforce development experience with Apex, Visualforce, triggers, batch Apex and Salesforce APIs 3+ years of experience configuring Salesforce using workflows, validation rules, enterprise territory management 2.0, roles & profiles, reports and dashboards; Understanding of the architecture, capabilities and constraints of Salesforce applications; Database experience writing queries in SQL/SOQ; Working with Data Loader or various ETL tools a plus; Experience integrating Salesforce with other applications using SOAP, REST, BULK APIs; Certified Salesforce Advanced Administrator or equivalent experience Certified Salesforce Platform Developer or equivalent experience; Certified Salesforce Platform App Builder or equivalent experience; Proficiency in HTML, XML, Flex, JavaScript, ASP, SQL, Java or C++, SOAP-based web services; BS in CS or related field and Masters preferred

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Import and Export Specialist

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Import and Export Specialist. As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

Responsible for ensuring import and export transactions are compliant with both US and International Customs rules and regulations.  The position acts as a liaison among several internal groups to ensure proper adherence to trade control laws and regulations.

Responsibilities

Properly classifies BVI products with the appropriate harmonized tariff code, ECCN and Country of Origin; Verifies and maintains international product data including tariff codes, ECCN and Country of Origin in the classification database; Provide shipment clearance instructions to BVI Customs Brokers, ensuring full compliance with CBP and other government agencies; Audit import entries for global BVI business units to ensure adherence to clearance instructions; Reviews and approves shipping documentation from overseas suppliers to ensure accuracy of documentation for a timely and efficient customs clearance process; Responsible for record retention of import/export documents in accordance with government regulations and Company policy; Assists with preparation for participation in government programs, such as CTPAT and ISA , in coordination with the Director, Global Trade Compliance; Participates in the creation of Import and Export Compliance procedures and work instructions; Prepares export documentation to ensure compliance with US Government laws and regulations and files Electronic Export Information in ACE; Prepares and maintains documentation in support of qualification of products under preferential trade programs; Knowledge of US trade laws and regulations such as the Export Administration Regulations (EAR), Office of Foreign Assets Control (OFAC) Regulations, US Customs and Border Protection Regulations, and other regulatory requirements; Supports investigations, internal and external audits, and other compliance initiatives as required by the business; Performs other trade management and compliance related duties as assigned.

Qualifications

Three to five years in Import/Export Compliance roles processing import and export transactions; Strong understanding of US Customs and Other Government Agency regulations, including FDA, is essential; Thorough knowledge of the Harmonized Tariff Schedule (HTS) and expertise in classification of a diverse range of products; Experience with EAR and OFAC Export compliance programs required; Bachelors degree or equivalent; Sitting for long periods of time; standing; squatting; reaching; computer work (typing), phone usage; filing; lifting up to 20 lbs. unassisted.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Business Data Analyst MDO

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Business Data Analyst MDO As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

The Business Data Analyst MDO is responsible for developing and executing policies/procedures that drive the collection, development, periodic review, and maintenance of master data that will drive process and system applications for Sales, Inventory, and Operations Planning (SIOP) for Beaver Visitec --in support of both Demand Planning and Master Planning. The incumbent will develop measurements for master data that will drive KPI’s and master data integrity reviews. Responsible for the accuracy, timeliness, and dissemination of all SIOP (Sales, Inventory, and Operations Planning) master data. The master data includes that which resides in Beaver Visitec information systems (IFS), and any master data in manual formats.
The scope for master data—as well as relevant business rules/policies—includes demand planning, master planning, production scheduling and sequencing, material purchasing, and logistics (transportation and warehousing). In addition to managing master data in the Beaver Visitec systems, the incumbent will publish communications to those who need to know of changes when they occur.

Responsibilities

  • Master Data entry and maintenance.
  • Project related activity/support
  • Tier 1 system support
  • Technical support to operations group.

This position requires a strong professional commitment to the customer coupled with a basic understanding of  supply chain and manufacuturing engineering principals;  Demonstrated highly effective interpersonal and communication skills, including the ability to work with business process owners; Strong organizational, planning, and analysis skills with demonstrated ability to work on multiple projects, manage outcome in conformance with organizational goals and objectives that produce positive results and meet project deadlines. Attention to accuracy and detail; Effective working knowledge of  Enterprise ERP systems, Microsoft office with intermediate to advanced Excel Skills;  Demonstrated ability to utilize time management skills and to effectively adapt to changing priorities; Effective customer service skills and ability to handle multiple tasks and time pressures; Ability to problem solve and effectively prioritize work, with the ability to balance attention between details and overall business objectives; Clear and effective written and oral communication skills; ability to communicate effectively and professionally with associates at all levels; Demonstrated ability to perform detail-oriented work with a high degree of accuracy; Demonstrated ability to follow established policies and procedures; Effective analytical, quantitative and problem solving skills; Committed to and actively works to continually improve. Ideally candidate will have SQL Programming capability and Power BI Experience.

Qualifications

Minimum of 2 years experience working in a business environment. Abilty to learn ERP funtionality and fields. Must be proficient at Excel, Word and MS Project; BS in Computer Science or Business Management; Knowledge of ERP systems, engineering data, master scheduling and MRP. Working knowledge of manufacturing in a medical device company or similar regulated industry.  Advanced Excel skills. Project Management; SQL Programming and Power BI Experience; Sitting for long periods of time; standing; squatting; reaching; computer work; phone usage; lifting up to 50 lbs. unassisted. Some travel required.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

 

Customer Service Representative

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures.  Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.  We have that “start-up” feel but have several well-established and recognized brands in our portfolio.  We are continuously striving to improve our existing products while creating new, innovative products as technologies and market needs change.

Beaver-Visitec International is currently seeking a Customer Service Representative As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

Responsibilities

The Customer Service Representative (CSR) will answer incoming calls from the customer service queue in a timely manner and will provide the highest level of customer satisfaction possible to both internal and external customers.  The CSR will be capable of processing RMAs in an expeditious and accurate manner, and will process customer orders (phone, fax and mail), special orders, drop ship orders and customer changes according to established department policies and procedures in a timely and accurate fashion.  The CSR will use an ERP system to provide prompt and efficient information to customers, call customers when necessary, and guide customers to other internal resources as necessary.  Document and resolve customer problems, complaints and issues promptly in a positive, win-win manner that will retain and promote customer loyalty in accordance with company processes.  Works effectively with others in a team environment to accomplish organizational goals and to identify and resolve problems.  The CSR will take initiative and personal ownership for meeting established individual and team metrics, and will meet or exceed monitoring standards on phones.

Qualifications

Associate’s degree and 2+ years of proven customer service experience or High School Diploma with 5-7 years of experience.  Bachelor’s degree and related (medical device) experience highly preferred.  Knowledge of customer service standards, procedures, principles and practices is desirable.  Demonstrated commitment to provide superior customer service must be evident.  Excellent PC/system skills, and be computer literate with the ability to learn software programs like Microsoft Office (Excel, Word, PowerPoint), Outlook and other databases (ERP Systems, ACT).  The CSR should possess strong data entry skills including accuracy, efficiency, and attention to detail, plus effective communication skills, both verbal and written, and comfortable interacting with customers and internal partners in a professional manner via the phone.  Previous knowledge of the Ophthalmic or Medical Device industry is a plus.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Surgical Sales Representative- DC/ Virginia

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Surgical Sales Representative As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

The Surgical Sales Representative is responsible for providing the highest level of support and satisfaction to BVI US Sales team and customers in support of sales growth objectives and delivering world class service experience for customers.  Assists sales staff with all phases of CustomEyes quoting, planning and order processing. The Sales Support Representative will serve as SME for CustomEyes products and process, IFS and Salesforce and will provide ongoing support to team members by entering all customer touchpoints in CRM, assisting with pipeline management, identifying product category sales opportunities and communicating information impacting customers to sales.

The Sales Representative will be based out of/    MUST live within Washington DC. (Ideal location within DC is Alexandria/Arlington area).

Responsibilities

Demonstrates Knowledge of Selling Skills:Experienced sales professional.  Capable of learning and applying technical knowledge base. Knowledge of selling process.  Strong clinincal selling skills. Responsible for translating selling skills knowledge into action and results; Demonstrates Effective Sales Abilities: Strategically approaches assignments with thorough understanding of customer needs, product attributes, revenue generation, profit and loss analysis. Skilled at making presentations to audiences at all levels. Demonstrated team selling skills. Responsible for utlizing strong selling skills in achieving and over-achieving anticipated customer expectations and BVI's sales goals; Demonstrates Relationship-building Skills:Demonstrated strong interpersonal skills., Builds effective business relationships with surgeons, staffs, and Key Opinion Leaders. Excellent communication skills; Business Acumen/Skills:  Ability to balance strategic and business actions.  Good understanding of current and potential future market trends, sales initiatives, and information affecting the business and organization.  Knows the competition; is aware of how strategies and tactics work in the OR (operating room) marketplace.

Qualifications

We require a BS or BA degree in Business and/or related discipline, 2 or more years selling medical devices in the operating room market to hospitals, surgery centers, and doctor’s offices.  Will consider ophthalmic pharmaceutical representatives.  (For BVI Internal Candidates there is a requirement of 6-9 months of BVI Sales related experience in addition to 2 years of general sales experience).  All candidates for this position should have a demonstrated track record of success and an aptitude to learn and apply new clinical knowledge.  Strong interpersonal skills (verbal and written) and the ability to foster and develop strong relationships is a must.  All candidates for this position must be proficient in the use of Microsoft Office and must be able to read and write in English; Candidates for this position should have a demonstrated track record of success and aptitude to learn and apply new knowledge.  Strong interpersonal communication skills (verbal & written) and the ability to foster and develop strong relationships is a must; Experience selling Ophthalmic medical devices preferred; Experience using a contact database or CRM tool; Saleforce.com experience

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Sales Support Representative

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Sales Support Representative As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

The Sales Support Representative is responsible for providing the highest level of support and satisfaction to BVI US Sales team and customers in support of sales growth objectives and delivering world class service experience for customers. Assists sales staff with all phases of CustomEyes quoting, planning and order processing. The Sales Support Representative will serve as SME for CustomEyes products and process, IFS and Salesforce and will provide ongoing support to team members by entering all customer touchpoints in CRM, assisting with pipeline management, identifying product category sales opportunities and communicating information impacting customers to sales.

Responsibilities

Provide the highest level of support to BVI US Sales Team; Point person for sales team and key customers for calls, e-mails, orders, CustomEyes support, pricing questions and problem resolution; Monitors Pipeline to drive sales and updates all activity in CRM; Participates in Sales Campaigns as directed; Support all aspects of our custom kit business (CustomEyes and Readypak); Process quotes for accuracy and approval; Communicates CustomEyes timeline milestones to Sales; Assists Sales by identifying product category opportunities; Documents customer touchpoints in CRM, updates contact data in IFS and CRM, schedule and follow up on open tasks.

Qualifications

2+ years of proven customer service experience (within BVI is preferred). Meets all skills required from general CS Rep requirements. Proficiency with IFS or other ERP System, Strong PC skills: Outlook, Office Suite.Ability to build rapport & foster strong relationships, able to manage time effectively, strong problem solving skills; Experience with Salesforce.com preferred; Associate's degree or 4+ years of related experience; Must be able to read/write in English. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and reach with hands and arms. Computer work; lift up to 20 lbs unassisted. Some travel may be required (Sales Meetings, Customer Site Visits, Tradeshows).

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Sr ERP Applications Manager

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Sr ERP Applications Manager As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

The Sr. ERP Applications Manager manages support, development initiatives and the rollout of all globally deployed business systems for BVI, including IFS and other systems as may be deployed by BVI. Identify areas/potential projects where process redesign/improvement can significantly impact efficiency, quality, profitability, competitive position and customer experience; work closely with Business Partners to ensure that process improvement projects support the strategic priorities of the organization; teach process improvement classes and coach process improvement practitioners across the company. Seeks out and champions new business and technology initiatives with company stakeholders.  Configures and maintains the IFS application suite and serves as project manager for future deployment of IFS modules. Manages 3rd party development resources needed to meet IT project timelines. Coordinates and manages EDI software, improvement initiatives, and projects for the addition of new partners and transaction sets as business requires.

Responsibilities

Provides clear leadership and support of IFS and other globally deployed systems consistent with the objectives of fulfilling BVI’s’s vision, mission, policies and procedures. Direct efforts toward high-value results.  Set goals and objectives. Ensure that 3rd party development organizations comply with BVI standards and procedures; Project Management – Prioritize projects, direct resources, manage projects on a day-to-day basis .  Arrange training as needed for users. Ensure that projects are on-time, on budget and meet the agreed to requirements of our IT customers; Work closely with Business and IT staff in BVI Regional and Global IT organizations.  Coordinate Plant and Business activities, implement Regional and Global initiatives for globally deployed Business Systems; Ensure that BVI Waltham globally deployed Systems are in compliance with BVI corporate directives, FDA regulations,  and ISO standards; Responsible for creating and managing project budget.  Will create capital requests as needed; Ensure that the Oracle database is supported and meets SLA commitments.

Qualifications

15+ years IT Experience; 10+ years working in an manufacturing environment. 10 + years of IFS or another large scale ERP application suite; 10+ years managing small to large IT deployment initiatives; 5+ years implementing MRP and Master Scheduling; Minimum of 2 IFS ERP implementations providing both technical and project management support; 1+ years exposure to Oracle Database Administration; 3 years Crystal report develop;  1-2 years of Business warehouse exposure;  (Cognos, BW, etc.); 1-2 years support of EDI environment work with 3rd party Vans; BS in CS or related field and Masters preferred.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Surgical Sales Representative- NY Metro

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty micro-surgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Surgical Sales Representative As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

The Surgical Sales Representative is responsible for providing the highest level of support and satisfaction to BVI US Sales team and customers in support of sales growth objectives and delivering world class service experience for customers.  Assists sales staff with all phases of CustomEyes quoting, planning and order processing. The Sales Support Representative will serve as SME for CustomEyes products and process, IFS and Salesforce and will provide ongoing support to team members by entering all customer touch-points in CRM, assisting with pipeline management, identifying product category sales opportunities and communicating information impacting customers to sales.

The Sales Representative will be based out of/MUST live within NY Metro Area.

Responsibilities

Demonstrates Knowledge of Selling Skills: Experienced sales professional.  Capable of learning and applying technical knowledge base. Knowledge of selling process.  Strong clinical selling skills. Responsible for translating selling skills knowledge into action and results; Demonstrates Effective Sales Abilities: Strategically approaches assignments with thorough understanding of customer needs, product attributes, revenue generation, profit and loss analysis. Skilled at making presentations to audiences at all levels. Demonstrated team selling skills.  Responsible for utilizing strong selling skills in achieving and over-achieving anticipated customer expectations and BVI's sales goals; Demonstrates Relationship-building Skills: Demonstrated strong interpersonal skills., Builds effective business relationships with surgeons, staffs, and Key Opinion Leaders. Excellent communication skills; Business Acumen/Skills: Ability to balance strategic and business actions. Good understanding of current and potential future market trends, sales initiatives, and information affecting the business and organization. Knows the competition; is aware of how strategies and tactics work in the OR (operating room) marketplace.

Qualification

We require a BS or BA degree in Business and/or related discipline, 2 or more years selling medical devices in the operating room market to hospitals, surgery centers, and doctor’s offices.  Will consider ophthalmic pharmaceutical representatives.  (For BVI Internal Candidates there is a requirement of 6-9 months of BVI Sales related experience in addition to 2 years of general sales experience).  All candidates for this position should have a demonstrated track record of success and an aptitude to learn and apply new clinical knowledge.  Strong interpersonal skills (verbal and written) and the ability to foster and develop strong relationships is a must.  All candidates for this position must be proficient in the use of Microsoft Office and must be able to read and write in English; Candidates for this position should have a demonstrated track record of success and aptitude to learn and apply new knowledge.  Strong interpersonal communication skills (verbal & written) and the ability to foster and develop strong relationships is a must; Experience selling Ophthalmic medical devices preferred; Experience using a contact database or CRM tool; Saleforce.com experience

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Design Quality Assurance Manager

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Design Quality Assurance Manager as a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

Reporting directly to the Sr. Director of Quality, the Design Assurance Quality Manager is a seasoned, experienced professional with wide-ranging experience and expertise in New Product Development and Sustaining quality engineering and oversight of DQA engineer direct reports.

Responsibilities

Accomplishes tasks through direct Execution and supervision of support of DQA engineers; Execute Quality Deliverable: Lead the execution of Quality Deliverable such as EUMDR, Project Design & Development Plan, Field Assessment Plan, and Design & Usability Validation Plans. Lead the execution of the Risk Management deliverable to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Lead product usability and design validation efforts for new product development and design change projects. Guides the successful completion of major programs and may function in a project leadership role; Design Controls: Providing quality and compliance input to the project team for project decisions and deliverable (e.g. Design & Development Plan, Product Specification, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured. Provide quality and regulatory guidance to assure country specific compliance to the laws and regulations of the targeted market for distribution. Champions 100% compliance to Company Policy and SOP’s. Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements; Suppliers: Provide product specific supplier and co-development quality assurance expertise during supplier audits, and through approval of supplier PDP and Design Controls deliverable. Measure and oversee the real-time continued quality of internal and external Component and Finished Good Suppliers. May represent the organization as the technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations. Uses diplomacy and tact to resolve difficult situations; Audit Support: Support internal and external regulatory audits; Product Support: Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques and evaluation criteria for obtaining results. Provide quality and compliance input and leads product development and/or post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, CAPA’s, HHAs, and Field Actions. Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies); Quality System Champion: Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized technical project teams which have a broad impact on the company utilizing cross-functional resources. Act as division representative on cross-divisional projects defining the quality system(s). Provides technical leadership to business units. Advise management on potential improvements or enhancement to quality systems and processes in the company. Support development, implementation and training of corporate quality initiatives.

Leads DQA efforts in conformity with EUMDR requirements; Identifies and implements effective risk management, usability, process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements; Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements; Act as leader in supporting quality disciplines, decisions, and practices; Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues; Assure the development and execution of streamlined business systems, which effectively and efficiently comply with procedural and regulatory requirements and are robust to identify and resolve quality issues; Support internal and external regulatory audits;Advise management on potential improvements or enhancement to quality systems and processes in the company; Leads design quality team on life cycle of the product from development to commercial sustainment; Leads quality team on product development projects of major magnitude and scope; Owns and drives deliverables related to EUMDR, Design Controls, Risk Management, Product Performance, Quality, and Compliance; key partner in all department goals and objectives; Develops and implements quality strategies; seeks innovative approaches to attaining quality goals; Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high-quality staff; Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly; Maintains and enhances cross-functional team relationships; Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues; Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives; Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

Qualifications:

In depth familiarity with the FDA, ISO, MDD/MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management; Detailed understanding and working knowledge of US and International regulations including 21CFR820, 803, 50, and 11 is required, as well as the Medical Device Directive/ Medical Device Regulation, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366; Strong communication and presentation skills; Competent with use of Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent); BS in Mechanical, Electrical, Biomedical Engineering, or other technical degree; Minimum of 10 years of Medical device engineering experience; 10+ years of medical device engineering experience preferred; 4 years minimum Quality leadership; Masters strongly preferred.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Principle Regulatory Affairs & Medical Affairs Specialist

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Principal Regulatory Affairs & Medical Affairs Specialist as a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

 The Principal RA & Medical Affairs Specialist basic Functions:

Regulatory and clinical supports new product development for global product development release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Supports the product lifecycle (e.g., Complaints, HHAs, PMS, PMCF, PSUR) through obsolescence by assessing regulatory changes made to the products and processes during post launch to determine regulatory impact of global changes to the current clearance/approvals or authorizations.

Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals for FDA, Europe (MDD and EU MDR), and other global, regional or state regulatory bodies for market authorization and maintenance of registrations and license.

Medical affairs for business based on clinical experience and/or product knowledge. Interface with KOLs and other appropriate medical experts in the field of Ophthalmology, ENT or other (MDs, surgeons) to support clinical experience and validation of clinical decisions related to patient or user hazards and/or benefits/risks. Viewed as divisional resource.

Responsibilities

Works with minimal supervision and instruction of more experienced staff; Takes a technical leadership role on one or more projects of significance e.g. global technical submissions; Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations; Demonstrates developing strategic and tactical technical leadership skills; Applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures; Demonstrates strong technical and project management skills, and is actively engaged in regulatory strategy, operations and activities spanning the product lifecycle, business/organizational activities; Demonstrate skills and knowledge in areas such as: strategy development, risk assessment and benefit/risk management; monitoring and communicating change in the regulatory environment as well as global communication; vendor development and management of international regulatory consultant and authorities; and influencing the regulatory environment; Plans, conducts and supervises assignments, reviewing progress and evaluating results; Recommends changes in procedures; Operates with substantial latitude for independent action or decision, and reviews progress with management.

Tasks may include:

Evaluating regulatory risks of corporate policies; Developing new global regulatory policies, procedures and SOPs and training key personnel e.g. US FDA, EU MDR or the rest-of-the-world (ROW) based on skill set and experience; Assisting in the development and advancement of policy and procedures for regulatory affairs and compliance to establish a compliant culture within the organization; Utilizing technical regulatory skills to propose strategies on complex issues; Monitoring emerging issues and identify solutions; Monitoring trade association positions for impact on company products; Providing regulatory input to product lifecycle planning; Anticipating regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams; Evaluating the effect of regulatory requirements on product positions; Assisting in the development of global, regional and multi-county regulatory strategy and updating strategy based upon regulatory changes; Determining submission and approval/clearance requirements; Monitoring regulatory outcomes of initial product concepts and provide input to senior regulatory management; Assisting in Regulatory due diligence and business integration(s); Technical writing, reviews and feedback e.g. Technical Submissions and Clinical Evaluations; Interviewing, and mentoring junior regulatory professionals; Successfully operates within Program Management principles.

Additional tasks may include:

Providing strategic input and technical guidance on regulatory requirements to development teams; Evaluating risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions; Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies; Managing and executing preapproval compliance activities; Assessing the acceptability of quality, preclinical and clinical documentation for submission filing; Negotiating and interacting with regulatory authorities during the development and review process to ensure submission approval/clearance; Identifying issues early in the submission preparation process that could impact product launch; Monitoring the impact of changing regulations, on submission strategies and update internal stakeholders, Prepare regulatory submissions; Proposing risk-based decisions on special access approval with appropriate regulatory agencies to pursue approvals based on patient needs and risk assessment; Maintaining annual licenses, registrations, listings and patent information; Ensuring compliance with product post-marketing approval requirements; Reviewing and approving labeling, advertising, and promotion materials to ensure compliance with regulations and company; Reviewing publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information; Reviewing and approving required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations; Providing regulatory input for and appropriate follow-up to inspections and audits; Developing, implementing and managing appropriate SOPs and systems to track and manage product-associated events; Submitting and reviewing change controls to determine the level of change and consequent submission requirements.

Qualifications

Ability to understand and explain detailed regulatory compliance programs and/or issues; Ability to comply with constantly changing regulatory procedures and prioritize work effectively; Ability to analyze and resolve non-routine regulatory issues using independent judgment; Must be able to observe and correct minute inconsistencies (e.g. in the written word, form usage, etc.); Ability to communicate and network with regulatory personnel to obtain relevant information; Must be able to work with cross functional teams; Ability to plan and conduct meetings; Ability to negotiate internally and externally with regulatory authorities (e.g FDA, Competent Authorities, Notified Bodies); Excellent analytical and writing skills; Effective interpersonal communication skills; Effective organizational skills; Advance PC skills; Previous experience in legal, technical or a regulated environment; 9 or more years of regulatory experience in the medical device industry; Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to lift, carry, etc. Generally involves sitting most of the time; Must be able to review printed material; Must be able to communicate with others telephonically; A. or B.S. in Science, Legal, Regulatory or Engineering, or equivalent; RAC certification or Advanced Degree (Masters in Regulatory Affairs) required; Certified ophthalmic assistant, technician or technologist; or surgical technologist a plus; Must be able to use common office equipment (e.g. PC, telephone).

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Senior Product Development Engineer

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver Visitec International is currently seeking a Senior Product Development Engineer as a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

Responsible for leading and managing high impact R&D initiatives including new opportunity identification, technology development, product development and line extensions in support of business objectives.

Responsibilities

Interact with other departments such as management, research, engineering, marketing and new business development to identify core technical competencies that fit with current business focus and potential new markets; Apply sound technical and business principles to investigate new product development opportunities; Support Sales and Marketing in defining market and customer needs and in developing a business plan in target markets; Specify design requirements for current and future products by working closely with sales, marketing and healthcare providers; Provide technical and project leadership over complex design, development and research projects; Effectively provide guidance to project teams in development of products and technologies from concept to commercialization while adhering to medical device design controls/regulatory requirements; Define product specifications, design inputs, product design, verification testing and supporting design validation studies; Perform engineering analyses to support new and existing designs; Fabricate prototypes with assistance from junior staff, technical support team and internal and external suppliers; Work with internal and external manufacturing partners to ensure producible designs (DFM); Contribute to company Intellectual Property Portfolio; Hold self and team members accountable to meet commitments; Ensure budgets and schedules are well planned and followed; Effectively communicate activity status, issues and mitigation plans with key stakeholders.

Qualifications

Minimum of 10 years of experience in product development in the surgical, disposable products or related industries; Experience interfacing and building relationships with Clinicians and KOL’s; Familiar with Concept Engineering (i.e., VOC, observational research, ODI, etc.); Proven track records of developing products from concept to launch; Knowledge of cGMP’s and FDA/CE Mark regulatory requirements; Experience with Design for Six Sigma (DFSS) tools and methodology; Minimum B.S. in Engineering discipline; Sitting and standing  for long periods  of time; bending; squatting; lifting up to 30 lbs; attending trade shows; observing surgery in OR.  Travel up to 20%.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Principal Regulatory Affairs Specialist

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Principal Regulatory Affairs Specialist as a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

Regulatory supports new product development for global product development release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Supports the product lifecycle (e.g., Complaints, HHAs, PMS, PMCF, PSUR) through obsolescence by assessing regulatory changes made to the products and processes during post launch to determine regulatory impact of global changes to the current clearance/approvals or authorizations.

Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals for FDA, Europe (MDD and EU MDR), and other global, regional or state regulatory bodies for market authorization and maintenance of registrations and license.

Responsibilities

Works with minimal supervision and instruction of more experienced staff;Takes a technical leadership role on one or more projects of significance e.g. global technical submissions; Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations; Demonstrates developing strategic and tactical technical leadership skills; Applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures; Demonstrates strong technical and project management skills, and is actively engaged in regulatory strategy, operations and activities spanning the product lifecycle, business/organizational activities; Demonstrate skills and knowledge in areas such as: strategy development, risk assessment and benefit/risk management; monitoring and communicating change in the regulatory environment as well as global communication; vendor development and management of international regulatory consultant and authorities; and influencing the regulatory environment; Plans, conducts and supervises assignments, reviewing progress and evaluating results; Recommends changes in procedures; Operates with substantial latitude for independent action or decision, and reviews progress with management.

Tasks may include:

Evaluating regulatory risks of corporate policies; Developing new global regulatory policies, procedures and SOPs and training key personnel e.g. US FDA, EU MDR or the rest-of-the-world (ROW) based on skill set and experience; Assisting in the development and advancement of policy and procedures for regulatory affairs and compliance to establish a compliant culture within the organization; Utilizing technical regulatory skills to propose strategies on complex issues; Monitoring emerging issues and identify solutions; Monitoring trade association positions for impact on company products; Providing regulatory input to product lifecycle planning; Anticipating regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams; Evaluating the effect of regulatory requirements on product positions; Assisting in the development of global, regional and multi-county regulatory strategy and updating strategy based upon regulatory changes; Monitoring regulatory outcomes of initial product concepts and provide input to senior regulatory management; Assisting in Regulatory due diligence and business integration(s); Technical writing, reviews and feedback e.g. Technical Submissions and Clinical Evaluations reviews; Interviewing, and mentoring junior regulatory professionals; Successfully operates within Program Management principles.

Additional tasks may include:

Providing strategic input and technical guidance on regulatory requirements to development teams; Evaluating risk of and regulatory solutions to product and clinical safety issues and recommend solutions; Evaluating proposed manufacturing changes for regulatory filing strategies; Managing and executing preapproval compliance activities; Assessing the acceptability of documentation for submission filing; Negotiating and interacting with regulatory authorities during the development and review process to ensure submission approval/clearance; Identifying issues early in the submission preparation process that could impact product launch; Monitoring the impact of changing regulations, on submission strategies and update internal stakeholders, Prepare regulatory submissions; Proposing risk-based decisions on special access approval with appropriate regulatory agencies to pursue approvals based on patient needs and risk assessment; Maintaining annual licenses, registrations, listings and patent information; Ensuring compliance with product post-marketing approval requirements; Reviewing and approving labeling, advertising, and promotion materials to ensure compliance with regulations and company; Reviewing publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information; Reviewing and approving required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations; Providing regulatory input for and appropriate follow-up to inspections and audits; Developing, implementing and managing appropriate SOPs and systems to track and manage product-associated events; Submitting and reviewing change controls to determine the level of change and consequent submission requirement.

Qualifications

Excellent analytical and writing skills; Effective interpersonal communication skills; Effective organizational skills; Advance PC skills; Previous experience in legal, technical or a regulated environment; 9 or more years of regulatory experience in the medical device industry; A. or B.S. in Science, Legal, Regulatory or Engineering, or equivalent; RAC certification or Advanced Degree (Masters in Regulatory Affairs) a plus; Certified ophthalmic assistant, technician or technologist; or surgical technologist a plus; Must be able to work with cross functional teams; Ability to plan and conduct meetings; Ability to negotiate internally and externally with regulatory authorities (e.g FDA, Competent Authorities, Notified Bodies); Ability to understand and explain detailed regulatory compliance programs and/or issues; Ability to comply with constantly changing regulatory procedures and prioritize work effectively; Ability to analyze and resolve non-routine regulatory issues using independent judgment; Must be able to observe and correct minute inconsistencies (e.g. in the written word, form usage, etc.); Ability to communicate and network with regulatory personnel to obtain relevant information; Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to lift, carry, etc. Generally involves sitting most of the time; Must be able to review printed material; Must be able to communicate with others telephonically; Must be able to use common office equipment (e.g. PC, telephone).

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

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