Senior Engineer, Design Assurance

📋 Description

• Manage and maintain Design History Files (DHF), ensuring documentation is complete, accurate
• Conduct regular DHF audits to identify gaps, maintain documentation integrity, and support ongoing
• Review and approve design requirements, Product Design Reviews (PDR), requirements matrices, and
• Collaborate with cross-functional teams to develop, review, and maintain risk management files and
• Review and approve Test Method Validation (TMV) protocols and reports, including Gage Repeatability
• Monitor post-market feedback for early-stage products, assess field performance, and prepare

🎯 Requirements

• At least 3 years of experience in Quality Engineering within the medical device industry
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements and their
• Demonstrated experience creating, reviewing, and maintaining Design History Files (DHF), risk
• Experience reviewing verification and validation (V&V) protocols and reports, as well as Test
• Strong ability to interpret complex engineering drawings and apply Geometric Dimensioning and
• Experience investigating nonconformances, conducting root cause analysis, and supporting quality

🎁 Benefits

• Competitive benefits package designed to support employee health, financial security, and overall
• Healthcare benefits and other employee support programs, with specific offerings determined by
• Paid time off to support work-life balance and personal well-being.
• Professional development opportunities in medical device quality engineering, design assurance, and
• Cross-functional collaboration with engineering, regulatory, clinical, and manufacturing
• Continuous improvement culture that encourages innovation, knowledge sharing, and the development