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R&D Engineer, Medical Devices

3 months ago

Irvine, United States Compunnel Inc. Full time

**LOOKING FOR CANDIDATES WITH PROFESSIONAL ENGINEERING EXPERIENCE. RESEARCH ASSISTANTS OR RECENT INTERNS WOULD NOT BE CONSIDERED**


Key Points:

  • -Prior experience as a sustaining engineer (R&D) in a medically regulated industry (Class II or III highly preferred)
  • -Design verification and validation experience in the medical device industry
  • -Basic understanding of Solidworks CAD system
  • -Exposure to failure mode analysis.
  • -PPK, MLTL, or any base level knowledge of statistical tools or analysis (Minitab use).
  • -Test method validation
  • -Design verification (plans & protocols), reporting, and testing
  • -Data failure analysis on the design verification testing

Key Responsibilities:

  • Test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
  • Generate work instructions, test methods, engineering drawings/prototypes, etc. to establish/characterize product and/or process specifications
  • Create/update portions of design control documents including requirement specs and risk documents
  • Assign R&D support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
  • Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers

Level of Independence:

  • -Works independently without close supervision
  • -Compares and evaluates possible courses of action after considering various possibilities
  • -Applies his or her knowledge in following procedures or in determining which procedures to follow or
  • determining whether specified standards are met
  • -Considers the cause and effect of activities exhaustive, and which allow room for creativity and judgment
  • -Direction tends to be high level and focused on end results with means of accomplishment left to
  • incumbent

Education & Experience Required

  • -Bachelor's degree in engineering required. Master's degree preferred.
  • -3 + years experience required.