Sr. Principal R&D Engineer - Yorba Linda, CA

Sr. Principal R&D Engineer - Infusion Disposables

Product Engineering is responsible for developing iterations, modifying, implementing and supporting existing products that function within the product families through adherence to established design control processes and good engineering practices.

  • Demonstrates strong working knowledge of Engineering principles and its application in solving complex technical problems with minimal guidance
  • Demonstrates working knowledge of medical device product design and development
  • Lead cross-functional project teams to complete Product Engineering projects with minimal guidance

Required:

  • BS degree in Mechanical Engineering or Biomedical Engineering or closely related disciplines with 12+ yrs relevant experience
  • Strong working knowledge of Engineering principles (mechanical and materials) and strong analytical and problem-solving skills
  • Must have experience with design and manufacturing of disposable products (plastics)
  • Experienced in mechanical/materials testing and test method development
  • Experience implementing product changes through a structured, phase-gated, product development process
  • Demonstrated experience in leading or supporting projects within a cross-functional team environment
  • Proficiency in SolidWorks or other equivalent 3D modeling software and familiarity with drawing standards
  • Proficiency in tolerance stack-up analysis involving multiple components
  • Understanding of fixture design including basic machining considerations, Measurement Systems Analysis (MSA)
  • Familiarity with statistical techniques
  • Demonstrated ability to clearly and effectively communicate (verbal & written)
  • Proficiency in Microsoft Project or equivalent project planning software

Preferred Qualifications:

  • MS or PhD in Mechanical Engineering or Biomedical Engineering
  • Experience with medical device design control preferred (high volume manufactured disposable products)
  • Clear understanding of manufacturing process validation
  • Good understanding of medical device product development risk management methodologies
  • Familiarity with statistical analysis software (e.g. Minitab)

Basic understanding of intellectual property (IP) considerations

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