Position Summary:

The Principal Verification & Validation Engineer leads the planning, execution, and documentation of verification and validation activities for medical device products. This role ensures product quality and regulatory compliance through comprehensive testing programs, while driving innovation in V&V methodologies and maintaining alignment with design controls and risk management requirements.

Responsibilities and Duties:

• Lead development and execution of verification and validation strategies
• Design and implement test protocols for product and process validation
• Develop validation master plans aligned with regulatory requirements
• Oversee design verification testing programs and documentation
• Lead process validation activities including IQ/OQ/PQ protocols
• Establish test methods and acceptance criteria for product testing
• Manage validation of manufacturing processes and equipment
• Direct software verification and validation activities
• Analyze and interpret test data using statistical methods
• Author comprehensive V&V documentation and technical reports
• Review and approve validation protocols and reports
• Ensure compliance with FDA, ISO 13485, and other regulations
• Support regulatory submissions with V&V documentation
• Collaborate with R&D, Manufacturing, and Quality teams
• Manage external testing laboratories and validation contractors
• Perform risk assessments and support risk management activities
• Lead investigation of test failures and implement corrections
• Support design reviews with V&V expertise and insights
• Maintain validation status of products and processes
• Drive continuous improvement in V&V practices
• Develop and maintain V&V procedures and work instructions
• Support quality system audits and inspections

Requirements:

• B.S./MS in Engineering (Biomedical, Mechanical, or Electrical preferred)
• 10+ years of V&V experience in medical device industry
• Expert knowledge of design controls and validation requirements
• Strong background in statistical analysis and DOE
• Experience with risk management per ISO 14971
• Proven track record of successful validation projects
• In-depth knowledge of FDA and ISO requirements
• Experience with software validation (IEC 62304)
• Strong project management and leadership skills
• Excellence in technical writing and documentation
• Experience with validation of automated systems
• Knowledge of sterilization validation requirements
• Proficiency in test method development and validation
• Strong problem-solving and analytical abilities

Preferred Qualifications:

• PhD in Engineering or related field
• ASQ CQE or similar certification
• Experience with human factors validation
• Background in product development
• Six Sigma certification
• Knowledge of process analytical technology (PAT)

Technical Skills:

• Statistical analysis software
• Test automation systems
• Quality management systems
• Data acquisition systems
• Project management tools
• Risk analysis tools
• Microsoft Office Suite
• Validation management software