Director of Validation and Verification

Job Description

My client is looking to add a Director of Validation and Verification to ensure multi-disciplinary engineering requirements, design outputs, verification and validation testing, and documented evidence meet all medical device quality management system regulations and standards relative to design control for the design development, and manufacturing of hardware, firmware, software and mechanical systems. 

Required Skills & Experience

• BS or MS in engineering or related field
• 5+ years of experience with medical device product design & development.
• Solid engineering fundamentals in electrical, mechanical, software, systems, and/or other fields.
• Medical device design, development, and regulatory requirements
• Experience working with third party suppliers of equipment and measurement systems.
• Solid hands-on experience in analog and digital electronic circuit testing, prototyping, board bring-up and troubleshooting.
• Solid hands-on experience in design, installation and qualification of electrical and mechanical systems, test fixtures and rigs.
• Experience prototyping systems with various sensors for biomedical applications.
  

What You Will Be Doing

• Develop test method plans, verification/validation plans/protocols, requirement traceability matrices, and summary reports in collaboration with cross-functional team members.
• Document and design verification and validation protocols and reports utilizing thorough knowledge of statistics, sample size determination, documenting sample size justifications/rationale and statistical data analysis of results.
• Lead a team of Test and Quality engineers for continuous updates and maintenance to documentation and execution of V&V protocols.

The Offer

• Base + Equity
• Health, Dental, Vision

*Cannot Sponsor now or in the future*