Senior Development Quality Engineer
Core
Senior Development Quality Engineer providing development and sustaining support for complex medical devices, specifically disposable catheters in the Electrophysiology division.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Disposable catheter medical devices for treating atrial fibrillation
Domain
Healthcare / Medical Devices / Electrophysiology
Required skills
Design verification and validation techniques, Applied statistics, Design of experiments, Regulatory compliance (FDA, IEC 60601, GMP, ISO 13485, ISO 14971), Root cause analysis, Design characterization
Preferred skills
Medical device experience
Technologies
Minitab
Responsibilities
Implement complex development projects including quality improvement initiatives, Execute Holistic & Strategic Design Verification/Validation Strategies, Lead design characterization activities, Influence design and verification decisions through applied statistics, Lead root cause investigations and corrective/preventive action activities, Ensure DHF content integrity and regulatory compliance, Serve as front-room representative during internal and external inspections.
Seniority
Senior, hands-on IC