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

Seeking a Sr. Principal R&D Engineer with 10+ years medical device, PhD in Mechanical or Biomedical Engineering and disposable products (plastics) experience for a global medical technology company.    

  • 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

Requirements:

  • PhD in Mechanical or Biomedical Engineering or related disciplines with 10+ yrs relevant experience

  • Strong working knowledge of Engineering principles (mechanical and materials) and strong analytical and problem-solving skills

  • 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:

  • 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 considerations

     

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