Validation Engineer

Job Description

We are seeking a qualified individual to prepare and execute Test Measurement Validation (TMV) protocols for medical devices. The role involves performing validation studies, documenting results, and ensuring compliance with ISO and regulatory standards.

• Prepare TMV protocols and reports and perform validation.
• Apply Gage R&R (repeatability & reproducibility) studies.
• Select appropriate measurement tools (e.g., vernier calipers, micrometers).
• Write clear TMV protocols, test procedures, acceptance criteria, and validation plans.
• Interpret test methods, specifications, and engineering drawings.
• Collaborate with Engineering, Quality, Operations, and R&D teams.
• Produce clear, audit‑ready documentation to meet ISO and regulatory requirements for medical devices.
• Train operators, engineers, and quality staff on validated inspection methods and best practices.

• Bachelor’s degree in Computer Science, Engineering, or a related field.
• Experience with TMV or similar validation processes in regulated environments.
• Strong knowledge of Gage R&R and measurement system analysis.
• Proficiency in selecting and using precision measurement tools.

• Discretionary Annual Incentive.
• Comprehensive Medical Coverage: medical, dental, vision, disability, pet insurance.
• Family Support: maternal & parental leaves.
• Insurance Options: auto & home insurance, identity theft protection.
• Convenience & Professional Growth: commuter benefits, certification & training reimbursement.
• Time Off: vacation, personal time off, sick leave, holidays.
• Legal & Financial Assistance: legal support, 401(k) plan, performance bonus, college fund, student loan refinancing.