Sr. Principal Engineer, Product Engineering - San Diego, CA

Are you a seasoned Sr. Principal Product Engineer with your Master’s Degree and 10+ years engineering experience? Do you have a strong plastics & medical device background, with a solid understanding of Design Controls and Principles (mechanical & materials)? If so, read on and let’s talk.

The Product Engineering Team, which you will be a big part of 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

Requirements:

  • MS degree in Mechanical Engineering or Biomedical Engineering or closely related disciplines (PhD preferred)

  • 10+ years of engineering experience

  • Advanced experience with design and manufacturing of disposable products (plastics)

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

  • 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 MS Project or other project 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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