Verification and Validation Engineer Job Description Template

The verification and validation engineer proves that a device meets its requirements and that those requirements meet the user’s actual needs. The two halves are distinct and both are required for regulatory clearance. The work is protocol driven, evidence heavy and unforgiving of shortcuts, since an incomplete test record can hold up a submission for months.

Typical Duties and Responsibilities

• Develop verification protocols traceable to design requirements
• Execute verification testing and record results formally
• Plan and support validation activities with representative users
• Maintain the traceability matrix across requirements, tests and results
• Investigate test failures and manage them through the defect process
• Write verification and validation reports for the design history file
• Support test method validation where measurement accuracy matters
• Review requirements for testability before they are approved
• Maintain test equipment calibration and configuration records
• Support audits and regulatory questions on test evidence

Education

• Bachelor’s degree in engineering, biomedical engineering or a related technical field

Required Skills and Experience

• 3+ years in verification and validation within medical devices
• Understanding of design controls and the difference between verification and validation
• Experience writing and executing formal test protocols
• Strong traceability discipline
• Ability to write reports that survive regulatory scrutiny
• Familiarity with ISO 13485 and ISO 14971
• Attention to detail in evidence collection
• Comfort working across software, hardware and systems teams

Preferred Qualifications

• Experience supporting an FDA submission
• Test automation skills