Katalyst Healthcares and Life Sciences
R&D Engineer with Medical Device
Katalyst Healthcares and Life Sciences, Irvine, California, United States, 92713
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.
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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.
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