R&D Engineer with Medical Device

Job Description :

We are seeking a motivated and innovative R&D Engineer to support the design, development, and testing of medical devices in compliance with FDA and ISO standards. The ideal candidate will work closely with cross-functional teams to bring new products from concept to commercialization.

Responsibilities :

• Design and develop medical devices and components from concept to production.
• Create design inputs, outputs, risk analysis, and test protocols.
• Perform design verification and validation (V&V) activities.
• Support prototype development, testing, and documentation.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and IEC 60601.
• Collaborate with quality, manufacturing, and regulatory teams throughout the product development lifecycle (PDLC).

Requirements :