R&D Engineer with Medical Device Job at Katalyst HealthCares and Life Sciences, Irvine, CA

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  • Katalyst HealthCares and Life Sciences
  • Irvine, CA

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.

Job Tags

Full time,

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