Principal or Sr. Principal R&D Engineer - Brea, CA

Are you a Principal or Sr. Principal R&D Engineer with a Bachelor or Master’s degree in Mechanical or Biomedical Engineering and have 8+ years of medical device product design & development experience and a strong plastics background.  If so, read on and let’s talk.

The Principal/Sr. Principal R&D Engineer will be part of our innovative Product Engineering team and design and development new products. Will be responsible for developing iterations, modifying, implementing and supporting new & existing medical device 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: 

  • BS/MS degree in Mechanical Engineering or Biomedical Engineering
  • 8+ years product design & development experience
  • Experience in medical device industry with strong knowledge of Engineering principles (mechanical & 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:

  • MS 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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