Senior Verification and Validation Engineer (Lead)

About the Role

Key Responsibilities

• Manage V&V resources with testing and debugging system software, serving as a technical bridge between software Development and V&V.
• Ensure rigorous adherence to design control documentation and internal procedures for post-launch activities, maintaining regulatory compliance and product quality standards.
• Develop requirements-based manual test procedures.
• Compile and analyze test results.
• Document and manage system software defects.
• Lead in regular scheduling, planning, resourcing, and team meetings.
• Participate in regular off-hour meetings with the business partner.
• Understand project goals and timelines, and provide technical leadership to ensure product launch success.
• Ensure optimal resource allocation and timely project completion while maintaining quality standards.
• Provide critical oversight in resolving field issues and maintaining product integrity throughout the lifecycle.
• Mentor and develop team members to help them grow professionally.
• Perform other work-related duties as assigned.

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.
• Knowledge 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.
• 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.
• Proficiency with computer skills including e-mail, word processing, statistical, spreadsheet, and graphing software.
• Knowledge of Application lifecycle management (Agile method preferred).
• Understanding of the software test cycle.
• Ability to write test plans, test cases, and test reports.
• Willingness to travel up to 10%, including airplane, automobile travel, and overnight hotel stays.

Nice to Have

• Experience with medical device software development under FDA regulations.
• Experience leading verification and validation teams.
• Familiarity with BL2 lab environment operations.

Qualifications

• Educational background as specified in requirements (B.S. or M.S. in relevant fields).
• Minimum 10 years of relevant experience, preferably in a medical device environment.

Benefits & Perks

• Salary range of $95,000 to $110,000, bonus eligible.
• Comprehensive benefits including medical, dental, vision, life, and disability insurance.
• 401(k) plan.
• Employee assistance program.
• Employee Stock Purchase Plan.
• Paid time off including sick time and holidays.
• Flexible work hours to meet project deadlines.