Technical Lead – Medical Device Design and Development

We are hiring for Technical Lead – Medical Device Design and Development

Experience Range -8 to 10 years.

Location - Bangalore, Pune, Kolkata, Chennai, Bhubaneswar, India

Job description -

• 8+ years of experience in orthopedics medical device product design and development. Preferably in new product development.
• Understanding of EU MDR (European Medical Device Regulation), FDA, ISO 13485, ISO 14971 requirements for medical devices.
• Strong experience in CAD NX (drawing, model, assembly etc.) and tolerance stack up analysis.
• Excellent understanding of GD&T principles.
• Knowledge to read and interpret information from Product design documents (CAD models and drawings etc.) and engineering analysis reports such as FEA
• Experience in medical device risk assessment techniques, design failure mode effect analysis (DFMEA), design control plans, product complain analysis.
• Understanding of various aspects of a Design History File (DHF) for medical device development.
• Experience in PLM change management (Windchill preferred)
• Should have led multiple large NPD / Reengineering / Value Engineering / Design Refresh programs

Roles & Responsibilities

Generic Managerial Skills, If any