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

BVI 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.

BVI 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.

BVI 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

BVI 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.

BVI 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.

BVI 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

BVI 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.

BVI 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.

BVI 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.

Jr. Staff Accountant

Overview

A Heritage of Precision, Innovation and Quality

BVI 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.

BVI is currently seeking a Jr. Staff Accountant, reporting to Accounting Manager, as a valued employee of BVI, 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. This position’s main responsibilities will be to support the Month-End closing process, Account Reconciliations, Intercompany Activity/Reconciliation, operating expense variance analysis for SG&A departments and budgeting and forecasting for the US based business.  These activities include, but are not limited to, month-end journal entries, account analysis, intercompany invoicing and reconciliation, balance sheet account reconciliations, assisting with the completion of department operating expense budgeting and forecasting.   In addition, this position will have membership on cross functional project teams as required. Month end close support including preparation of monthly journal entries, account analysis and account reconciliations.  Owner of all month-end documentation for close process.  Reviews existing processes and makes recommendations/implement improvements.  Ensures all close related deadlines are met. Prepares monthly actual vs. budget apex analysis and variance explanations. Ad hoc projects/analysis as required.

Qualifications

BS / BA in Business, Finance, or Accounting, with Strong analytical skills.  1 to 3 years of experience in computerized accounting systems required.  Additionally, this individual must perform well in a team-based work culture. Strong Excel Experience in the month-end close process; experience in medical device industry a plus – Preferred:  Experience in the month-end close process; experience in medical device industry a plus. Sitting for long periods of time; standing; squatting; reaching; computer work (typing), phone usage; faxing; filing; lifting up-to 20 lbs. unassisted.

BVI 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 Program Manager

Overview

A Heritage of Precision, Innovation and Quality

BVI 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. BVI is currently seeking a Principal Program Manager, reporting to the Director or VP, R&D.  They will oversee all aspects of product development from the earliest definition of the product concept through commercialization in all global markets. Focus in on complex program/platform technologies. Lead cross-functional group comprising product development, quality, regulatory, clinical, manufacturing, and marketing to develop, communicate and measure progress against goals and metrics for program success.

Responsibilities

Lead cross-functional group comprising product development, quality, regulatory, clinical, manufacturing, and marketing to develop, communicate, and measure progress against goals and metrics for program success. Oversee all aspects of product development from the earliest definition of the product concept through commercialization in all global markets. Manage project and product cost against budget; reports and advises on recovery plans necessary to achieve budget targets. Coordinate with leaders of manufacturing to plan and execute transfer of products from design to production. Partner with clinical researchers, clinical organization, corporate resources, marketing, and external stakeholders to plan and execute clinical studies for regulatory approval and to support reimbursement. Exercise performance management of all team members in cooperation with respective functional managers. Participate in portfolio analysis and the development of portfolio value and value-based decision making of where to deploy human capital to maximize portfolio value.

Qualifications

BS Mechanical Engineering, Biomedical Engineering, Life Sciences, or Electrical Engineering degree required. (MS. or PhD preferred.) Five to ten years of experience in product development leadership in the surgical, disposable medical products or related industries with specific experience in products involving complex clinical and regulatory considerations. Good verbal and written communication with all levels of division and corporate leadership. Knowledge of GMP’s, current FDA Medical Devices legislation and regulations. Must be able to travel domestically and internationally up to 20% based on needs of the project/team.   standing; squatting; reaching; computer work (typing), phone usage; faxing; filing; lifting up-to 20 lbs. unassisted.

BVI 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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