Sr. Product Engineer - San Diego & Yorba Linda, CA

Are you a Sr. Product Engineer with 5+ years of medical device product design and development AND have  a strong plastics background?  Do you have a degree in Mechanical Engineering or Biomedical Engineering and are proficient in SolidWorks or other 3D modeling?  Are you authorized to work in US?  If so, read on and let’s talk.

Responsibilities:  Working in a global medical technology company, the Sr. Product Engineering is responsible for developing iterations, modifying, implementing and supporting existing products that function within our medical device 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

    Qualifications

  • BS degree in Mechanical Engineering or Biomedical Engineering or closely related disciplines

  • 5+ years of medical device product design and development 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)

  • Proficiency in SolidWorks or other equivalent 3D modeling software and familiarity with drawing standards

  • 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 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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