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    1 month ago

    Santa Rosa, United States Grove Technical Resources, INC Full time

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  •  Sr R/D Engineer-Medical Device-Only W2

    2 weeks ago

    Santa Rosa, United States Grove Technical Resources, INC Full time

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  •  Sr R/D Engineer-Medical Device-Only W2

    2 weeks ago

    Santa Rosa, United States Grove Technical Resources, INC Full time

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    Santa Ana, United States Intellectt Inc Full time

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    Santa Ana, United States Intellectt Inc Full time

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  • R&D Engineer II

    4 weeks ago

    Santa Rosa, United States Grove Technical Resources, INC Full time

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  • R&D Engineer II

    4 weeks ago

    Santa Rosa, United States Grove Technical Resources, INC Full time

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  • R&D Engineer II

    3 weeks ago

    Santa Rosa, United States GROVE TECHNICAL RESOURCES, INC Full time

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  • Principal R&D Mechanical Engineer

    3 weeks ago

    Santa Clara, United States Cortex Full time

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    3 months ago

    Santa Rosa, United States Artech LLC Full time

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    3 weeks ago

    Santa Rosa, United States ATR International Full time

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  • Senior R&D Engineer

    1 week ago

    Santa Rosa, United States ATR International Full time

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R&D/NPD Engineer(Medical device)

1 month ago

Santa Ana, United States Intellectt Inc Full time

Responsibilities:

  • Lead and contribute to the design, development, and testing of new medical devices in accordance with project goals and regulatory requirements (e.g., FDA, ISO).
  • Develop and implement robust test methods and protocols for design verification and validation activities.
  • Conduct feasibility studies, risk assessments, and ensure compliance with regulatory standards throughout the product development lifecycle.
  • Collaborate with manufacturing engineering to optimize designs for manufacturability, scalability, and cost-effectiveness.
  • Work closely with manufacturing teams to transfer new products into production, ensuring smooth transition and adherence to quality standards.
  • Generate and maintain detailed design documentation, including specifications, drawings, and reports.
  • Support regulatory submissions and address any design-related queries from regulatory bodies.
  • Stay current with industry trends, technologies, and best practices to drive innovation and continuous improvement.

Requirements:

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field (Master’s degree preferred).
  • 6 years of experience in R&D/NPD within the medical device industry.
  • Proficiency in CAD software (e.g., SolidWorks) and familiarity with design control processes.
  • Strong analytical skills and ability to solve complex technical problems.
  • Experience with test method development, validation protocols, and statistical analysis.
  • Knowledge of manufacturing processes, materials, and quality systems (e.g., Six Sigma, Lean Manufacturing).
  • Excellent communication skills and ability to work effectively in a team environment.
  • Knowledge of regulatory requirements and standards (e.g., FDA 21 CFR Part 820, ISO 13485).