Senior Development Quality Engineer
Core
Senior Quality Engineer providing development and sustaining support for complex disposable catheter medical devices in the Electrophysiology division, overseeing projects from concept to launch.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Disposable catheter medical devices for treating atrial fibrillation
Domain
Healthcare / Medical Devices / Electrophysiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design verification and validation techniques, Applied statistics, Design of experiments, Root cause analysis, Regulatory compliance (FDA/ISO), Design characterization, Method validation
Preferred skills
Medical device experience, Statistical software tools (Minitab)
Technologies
Minitab
Responsibilities
Implement complex development projects including quality improvement initiatives, Execute Holistic & Strategic Design Verification/Validation Strategies, Lead design characterization activities, Lead root cause investigations and corrective/preventive actions, Ensure DHF content integrity and regulatory compliance, Serve as front-room representative during internal and external inspections
Seniority
Senior, hands-on IC
