Senior Engineer, Design Assurance
Accountabilities Manage and maintain Design History Files (DHF), ensuring documentation is complete, accurate, traceable, and compliant with applicable quality requirements.
Conduct regular DHF audits to identify gaps, maintain documentation integrity, and support ongoing regulatory compliance.
Review and approve design requirements, Product Design Reviews (PDR), requirements matrices, and engineering change orders, ensuring appropriate verification and validation (V&V) activities are defined and completed.
Collaborate with cross-functional teams to develop, review, and maintain risk management files and related documentation, including ensuring risk assessments are updated alongside design changes.
Review and approve Test Method Validation (TMV) protocols and reports, including Gage Repeatability and Reproducibility (Gage R&R), to confirm measurement systems are reliable before V&V execution.
Monitor post-market feedback for early-stage products, assess field performance, and prepare Post-Market Surveillance (PMS) reports and field feedback reviews.
Investigate nonconformance reports (NCRs), perform root cause analysis, and support corrective actions and continuous quality improvement.
Provide design quality guidance to engineering and other stakeholders, promoting compliance with established design controls and quality management processes.
Support continuous improvement initiatives that strengthen product quality, risk management, and regulatory readiness.
Requirements
At least 3 years of experience in Quality Engineering within the medical device industry, specifically in Design Quality or Design Assurance.
Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements and their application to medical device development.
Demonstrated experience creating, reviewing, and maintaining Design History Files (DHF), risk management documentation, Design Failure Mode and Effects Analysis (DFMEA), Use Failure Mode and Effects Analysis (UFMEA), and Process Failure Mode and Effects Analysis (PFMEA).
Experience reviewing verification and validation (V&V) protocols and reports, as well as Test Method Validation documentation, including Gage R&R studies.
Strong ability to interpret complex engineering drawings and apply Geometric Dimensioning and Tolerancing (GD&T) principles.
Experience investigating nonconformances, conducting root cause analysis, and supporting quality improvement activities.
Proficiency in Microsoft Office applications and technical documentation.
Excellent communication, analytical thinking, problem-solving, organizational, and leadership skills, with the ability to collaborate effectively across multidisciplinary teams.
Willingness and ability to travel internationally on occasion.
Preferred qualifications:
Six Sigma Green Belt certification.
Certified Quality Engineer (CQE) credential.
A bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical discipline.
Benefits
Competitive benefits package designed to support employee health, financial security, and overall well-being.
Healthcare benefits and other employee support programs, with specific offerings determined by location.
Paid time off to support work-life balance and personal well-being.
Professional development opportunities in medical device quality engineering, design assurance, and regulatory compliance.
Cross-functional collaboration with engineering, regulatory, clinical, and manufacturing professionals.
Continuous improvement culture that encourages innovation, knowledge sharing, and the development of technical expertise.
Meaningful work contributing to the safety, reliability, and effectiveness of medical technologies that support patient care.
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