Title: Senior Instrument Verification and Validation Engineer

Job Location: Rochester, NY

Job Duration: 12+ months

NOTE:

• 20% of travel includes airplane, automobile travel and overnight hotel.
• Overtime is expected. Early or late meetings with China Partners

Job Description:

• As we continue to grow as ***, we are seeking a Verification and Validation SR Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA.
• The individual will be part of an engineering team that is responsible for requirements based manual test case design and execution of test procedures in a BL2 lab environment.
• The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with software development and partners to reproduce and verify system defects.
• Designing and implementing software for embedded devices and systems.
• Designing, developing, coding, testing, and debugging system software.
• Develop Requirements based manual test procedures.
• Access requirements for testability and determine the best test approach.
• Compile and analyze test results.
• Document and manage system software defects.
• Participate in regular scheduling and team meetings.
• Participate in regular off hour meetings with partner in China.
• Understand project goals and timelines and provides support to ensure product launch success.
• Perform other work-related duties as assigned.

Required Skills:

• B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline required.
• 10+ years required, preferably in a medical device environment.
• Familiarity with software configuration management tools, defect tracking tools, and peer review.
• Instrument V&V Theory & Application.
• An understanding of IEC 62304 (Medical Device Software – Lifecycle process), ISO 13485, ISO / EN ISO 14971, and FDA QSR experience or equivalent FDA software development requirements.
• Experience in product development and experimental design.
• Ability to participate in planning and managing projects.
• Working knowledge of product development tools and processes (e.g. Design Input, Design Output, Verification and Validation, Product Risk Management).
• Knowledge of related quality systems regulations and processes.
• Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software).
• Knowledge of Application life cycle management (Agile method preferred).
• Know and understand the software test cycle.
• Ability to write test plans, test cases and test reports.