Senior Verification and Validation Engineer (Lead)

We are seeking a Senior Software Instrument Verification and Validation Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will lead and 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.

Requirements

• B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline
• 10+ years of experience, preferably leading in a medical device environment
• Strong knowledge of software configuration management tools, defect tracking tools, and peer review
• Strong understanding of 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
• Strong analytical and problem-solving skills
• Strong organizational skills and the ability to manage multiple tasks
• Experience in product development and experimental design
• Ability to work within cross-functional teams
• Strong communication skills, written and verbal
• Must exhibit professionalism, confidence, maturity, desire to succeed, and a self-motivated and proactive orientation
• Ability to participate in planning and managing projects
• Strong working knowledge of product development tools and processes (e.g., Design Input, Design Output, Verification and Validation, Product Risk Management)
• Strong knowledge of related quality systems regulations and processes
• Appropriate computer skills (e.g., email, word processing, statistical, spreadsheet, and graphing software)
• Knowledge of Application life cycle management (Agile method preferred)
• Must know and understand the software test cycle
• Must have the ability to write test plans, test cases, and test reports

Benefits

• Medical, dental, vision, life, and disability insurance
• 401(k) plan
• Employee assistance program
• Employee Stock Purchase Plan
• Paid time off (including sick time)
• Paid Holidays