R&D Engineer with Medical Device
R&D Engineer with Medical Device
Posted on :
21-07-2025
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1 Vacancy
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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:
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).
- 3 7 years of experience in R&D within the medical device industry.
- Bachelors or masters 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.
Employment Type
Full-time
Key Skills
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