Job Description
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.