We are looking for an experienced Junior to Senior Product Development Engineer to lead the design, development, and sustenance of Class II/III medical devices.
Key Responsibilities:
Manage medical device design and development activities, including design control documentation and DHF.
Handle risk management activities as per ISO 14971, including DFMEA.
Develop and execute Verification & Validation (V&V;) plans, protocols, and reports.
Ensure compliance with ISO 13485, IEC 60601, FDA, and EU MDR requirements.
Collaborate with cross-functional teams for design reviews, process validation, and design transfer.
Support regulatory submissions, including 510(k) and CE Mark.
Experience: Junior to senior level medical device design and development.
Location: Chennai
Pay: ₹11,000.00 - ₹40,000.00 per month
Work Location: In person
📌 Design & Quality Engineer Chennai
🏢 Hirely
📍 Chennai
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