Sr. Quality Engineer - Post-Market Vigilance - Onsite

Senior Quality Engineer to lead post-market investigations of neurovascular medical devices, evaluating product performance signals, determining root causes, and developing risk controls. The role partners across R&D, manufacturing, regulatory, and clinical teams to ensure device safety and regulatory compliance.

Responsibilities

• Lead engineering investigations of post-market complaints and device failure modes to assess patient and product impact.
• Plan technical investigations using returned-device analysis, test data, and manufacturing records to determine root cause.
• Apply risk management principles to evaluate whether post-market information changes hazards, failure modes, or control adequacy.
• Perform complaint trending and signal detection to identify emerging product performance issues and distinguish meaningful signals.
• Translate engineering evidence into recommendations for product holds, corrective actions, and design improvements across cross-functional teams.

Requirements

• Bachelor's degree with 4+ years quality or engineering experience
• Master's degree with 2+ years relevant experience, or Ph.D.
• Strong statistical data analysis and complex dataset interpretation skills
• Knowledge of medical device design, risk management, and FDA/international standards
• Problem-solving expertise in failure mode analysis and root cause investigation