We, at BVI, are always seeking engaged, innovative, and talented professionals who are interested in growing their career within the ophthalmic industry. We seek individuals who are looking to constantly learn, collaborate and advance eye health across the globe.  Valued BVI employees enjoy a complete benefits package plus a competitive salary. Benefits are individually discussed at time of offer of employment.

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

Sr. Design 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 Sr. Design 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. The Sr. Design Engineer responsible for leading and participating in R&D inititiaves including new opportunity identification, technology development, product development and line extensions in support of business objectives.

Responsibilities

BS in Mechanical Engineering or Equivalent / 5+ years of medical device development experience, specifically with expertise in implant technology, disposable devices and capital equipment. Proven experience driving technical leadership in the design of surgical devices utilizing plastic, disposable device design including DFM/DFA. Interacting with suppliers to obtain quotes and assess component manufacturability from a wide variety of sources, including CNC machining, sheet metal, textiles, formed metal tubular components and injection molding. In-depth knowledge of rapid-prototyping and volume manufacturing processes including 3D printing, CNC machining, and injection molding.  Ability to build prototypes and critically evaluate performance of design concepts and device prototypes. Ability to drive CAD designs to bring early stage concepts through to cost-effective manufacturing and sourcing. Experience generating and maintaining design output drawings/specification including drafting, tolerancing, and DFM for manufacture. Extensive knowledge in analyzing and solving problems in a disciplined fashion, ensuring clear understanding of the root cause(s) and efficient recommendations for resolution. Proficient in SolidWorks, PTC Creo, Visio, Minitab, and Microsoft Office Suite including Excel, Word, PowerPoint and Outlook.

Qualifications

Active / lead participant in at least one full concept-to-market (medical) device development cycle preferably in a highly regulated environment. Project management skills including MS Project highly desirable, with the ability to align and balance potentially conflicting internal and external resources. Design engineering experience leveraging prototype fabrication using 3D printer experience, light machine tools experience, working knowledge of the requirements of contract machine shops and job shops to ensure rapid turn-around on high-quality parts and assemblies. Broad knowledge of medical device and standard computer systems including selection of appropriate platforms and suppliers for hardware.

Sitting for long periods of time; standing; squatting; reaching; Attending Trade shows & Travel up to 15%, Possibly more depending on specific projects.  Lift up to 30lbs, 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.

Sr. Sales Representative- Colorado

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 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 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 in Denver Colorado 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.

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.

Senior Quality Systems 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 Senior Quality Systems 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 Senior Quality Systems Specialist will support the planning, implementation and maintenance of the BVI Quality Management System and reports to the Principal Quality Systems Engineer.

Responsibilities

The Quality Systems Specialist supports the development and maintenance of quality system programs, policies, processes, procedures and controls ensuring that performance and quality of the Quality Management System complies with regulation, standards and agency guidelines. Reviews, analyzes and reports on quality performance and processes and develops corrective actions for recurring discrepancies. Submits appropriate metrics and reports to the site quality management and/or to corporate as part of the Management Review process. Interface with assigned cross functional global departments, manufacturing, engineering, customer, vendor and subcontractor representatives to facilitate compliance, Supporting Internal and External Audits. Reviews and monitors compliance with GXP practices. Maintains compliance to the BVI Corporate Quality Management System; manage and maintain effectiveness of Quality Management System; supports submittal of reports summarizing various trend analyses on their defined and applicable quality system clauses and corresponding quality objectives; facilitates the awareness of quality, regulatory and customer requirements throughout the organization. Potentially lead and/or coordinate QMS Review Boards (e.g. CAPA Review, Complaint Review) Assists in the development and continuous improvement of SOPs and Work Instructions. Encourages robust problem-solving methodologies, Enable sharing of initiatives/ideas and accomplishments across the business.

Qualifications

BS- BA in a relevant discipline , MS in a relevant discipline, ASQ Certification (e.g. CQA, CBA) strongly preferred; 3-5 years of medical device industry experience .Detailed understanding and working knowledge of US and International regulations including 21CFR820, 803, 806, 807 and 11 (Required), as well as the Medical Device Directive/ Medical Device Regulation, EN ISO 13485, EN ISO 14971, and other standards applicable to the international medical device industry. Experience with implementation and maintenance of multiple Quality System Elements. Strong technical writing, communication and presentation skills. Competent with use of Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent). Applies continuous improvement principles in development of the quality system elements. Driven, energetic, self-assured professional with high personal integrity. Ability to develop effective, positive interpersonal relationships.

Preferred: 5+ years of medical device experience. Certified Green Belt strongly preferred. ISO 13485 training, experience in complaints, internal auditing and CAPA methodologies/systems. Experience in working in a global, matrixed organization. Experience with the planning, implementation and maintenance of an Electronic QMS Solution. Experience supporting external audits and coordinating Audit Response activities.
Sitting for long periods of time; standing; squatting; reaching; computer work (typing) phone usage; filing; lift to 20lbs, 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.

Director or Senior Director, Clinical & Regulatory Affairs

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 Director or Senior Director, Clinical & Regulatory Affairs. 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 Director or Senior Director of Clinical and Regulatory Affairs will lead the strategic direction and operational aspects of clinical development, global regulatory compliance and submissions for BVI Class I, II and III medical devices. The incumbent functions as the regulatory subject matter expert for PMA filings and Clinical Trials. This position will be responsible for developing a strategic clinical and regulatory plan through pivotal IDE trials, developing strong relationships and obtaining regulatory approvals from the FDA and other global regulatory agencies. The Director or Senior Director will develop strategic direction and priorities for clinical development, working with R&D, Marketing and Quality leadership to define clinical development projects including objectives, work plans, milestones and deliverables.  This role will Work with internal and external parties to design and execute pivotal clinical trials in line with Good Clinical Practice, BVI SOPs, FDA guidelines, and ISO standards (as applicable), including prioritizing indications, choosing appropriate populations and endpoints, planning and executing statistical analysis, and identifying risks. Provide overall clinical site management from qualification/start-up to closeout, including training, site initiation, CRF review, protocol and regulatory compliance, device accountability, and visit reports. They would develop and implement a regulatory strategy and related activities needed to demonstrate safety and effectiveness and to reach premarket notification and/or approval.  They will actively support the regulatory submission process, acting as a point of contact for FDA or other regulatory bodies. The Director or Senior Director will be expected to ensure regulatory compliance of BVI’s devices with the FDA and other applicable regulatory jurisdictions, identifying and assessing regulatory risks.

Qualifications

Requirements:   BS or higher in a technical or clinical discipline (engineering, biology/life sciences)

Preferred: Master’s degree in technical or clinical discipline. Ophthalmology background.    10+ years clinical research exp., in a medical device setting (prefer Experience within ophthalmology. ) Experience with Class I, II and III medical devices. Previous experience in a pivotal IDE trial. Demonstrated experience with major regulatory submissions – PMA, 510(k), etc. Excellent analytical skills required; (some formal training in statistics is preferred).   Positive, self-motivated, detailed, and hands-on, with the ability to work independently as well as collaboratively across BVI Innovation Units.

Sitting for long periods of time; standing; squatting; reaching; computer work (typing), phone usage; filing; lift to 20lbs. 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.

Customer 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. 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.

Responsibilities

We are currently seeking a full-time temp-to-regular Customer Support Representative to join the US customer service team. The Customer Support 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

Requirements: Associate degree or (equivalent 2 yr. College) and 2+ years of proven customer service support 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.

Must be able to read/write English. While performing the duties of this job, 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 20lbs 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.

 

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