Sr. R&D Engineering Manager - Brea, CA

Seeking a strong Sr. R&D Engineering Manager for a newly created role with medical device experience and ability to lead a team of 6-8 engineers. 

Responsibilities: 

  • Will develop and implement 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
  • Managing 6-8 direct functional reports in an R&D organization
  • Build, grow & mentor a team of R&D/New Product Dev Engineers
  • Ability to set a vision and engage own team to reach that vision
  • Leads through building relationships; demonstrated facilitation skills across different functions; motivated by collective success
  • Determines resource needs for new product development and existing product support and assigns personnel as appropriate
  • 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 degree in Mechanical Engineering or Biomedical Engineering or closely related disciplines with 10+ years relevant experience
  • Charismatic leadership style with excellent collaboration and communication skills
  • Minimum of 5 years of functional management with direct reports
  • 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 developing high-volume products
  • 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)
  • Knowledgeable in Design for Six Sigma and solid experience in statistical techniques
  • Demonstrated ability to clearly and effectively communicate
  • Proficiency in Microsoft Project or equivalent project planning software

Preferred:

  • 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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