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Product Development Engineer

Job ID: 221828

Location: Irvine, California , US, 92614

Summary:

To perform technical work to develop proprietary medical devices from concept through manufacturing and launch.

Project Details:

  • Technical Leadership (50%)
  • Participate as a technical role on multiple cross-functional development teams that manage projects from concept through commercialization
  • Assist in conceptualization, design and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements
  • Contribute to design/development of product line extensions and product improvements
  • Accurately and efficiently assist with translating user and patient needs through design requirements, design specifications, and into verified/validated devices and procedures
  • Resolve technical problems
  • Design, assemble and evaluate rapid prototype models in order to assess technical feasibility of various solutions
  • Communication (20%)
  • Communicate project plans and status cross-functionally to facilitate the product development process
  • Author protocols and reports including engineering studies using basic statistical methods
  • Communicate with outside suppliers as needed
  • Laboratory and Production (30%)
  • Assist with verification and validation activities through regulatory clearance and design transfer
  • Develop robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements

Job Experience:

  • Bachelor's Degree in Engineering or related technical field or 5 + years work related experience
  • Ability to apply analytical skills and scientific technical principles in problem solving and development
  • Demonstrated computer skills preferably Solidworks, spreadsheets, word processing, database and other applicable software programs
  • Strong interpersonal and organizational skills and the ability to work effectively as a team member
  • Working knowledge of United States and international standards as applicable to the department
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