R&D Engineer with Medical Device
2 days ago
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.
- 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.
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R&D Engineer III
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Irvine, CA, United States Kasmo Global Full timeR&D Engineer III Location: Irvine, CA Employment Type: Contract /Onsite Job Duties: Design and development of combination products and medical devices, ensuring compliance with industry standards and regulations. Apply knowledge of system engineering, risk management, and usability engineering throughout the product lifecycle. Perform design work...
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Irvine, CA, United States Kasmo Global Full timeR&D Engineer III Location: Irvine, CA Employment Type: Contract /Onsite Job Duties: Design and development of combination products and medical devices, ensuring compliance with industry standards and regulations. Apply knowledge of system engineering, risk management, and usability engineering throughout the product lifecycle. Perform design work...
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