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

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

The Research and Development Engineering Team, which you will be a big part of is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation 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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