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:

• 3-7 years of experience in R&D within the medical device industry.
• Bachelor's or master's in biomedical, Mechanical, or related Engineering field.
• Strong knowledge of design controls, V&V, risk management (FMEA).
• Experience with CAD tools (e.g., SolidWorks) and lab testing equipment.
• Familiarity with biocompatibility, sterilization, and material selection.
• Strong documentation and communication skills.