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Principal Mechanical Engineer (Irvine)

Principal Mechanical Engineer (Irvine)

SoloPoint SolutionsIrvine, CA, US
1 day ago
Job type
  • Part-time
Job description

This role does NOT offer relocation assistance, visa sponsorship or corp-to-corp arrangement. Only local candidates will be considered

Location : Irvine, CA (On-site)

Company Overview : We are a leading innovator in the design and manufacturing of custom-fitted prosthetic devices. As our business continues to experience significant growth, we are preparing for major new product introductions scheduled for 2026 and beyond. We are seeking a talented engineer to play a pivotal role in our expansion.

Key Responsibilities :

  • Serve as the technical lead and subject matter expert (SME) for the design and development of advanced mechanical systems.
  • Lead the design, development, and release of detailed components, subsystems, and complex mechanical systems from concept to launch.
  • Develop and execute comprehensive verification and validation (V&V) plans, protocols, and reports to ensure products meet design specifications and regulatory requirements.
  • Collaborate with legal teams to prepare and submit intellectual property filings, including patents and invention disclosures.
  • Create and manage project budgets and timelines, ensuring projects are delivered on time and within financial scope.

Required Qualifications :

  • Bachelor's Degree in Mechanical Engineering or Mechatronics Engineering.
  • A minimum of 7 years of experience in R&D and product development within the medical device industry.
  • Proven track record of leading projects through the entire product lifecycle, from initial concept through commercial launch.
  • Advanced development experience with hydraulic, pneumatic, or other complex actuation systems.
  • Expert proficiency with SolidWorks and strong skills in Finite Element Analysis (FEA).
  • Preferred Qualifications :

  • An advanced technical degree (Master's or Ph.D.).
  • Direct experience with robotics design.
  • Demonstrated experience with design transfer to manufacturing.
  • Thorough understanding of relevant industry standards and regulations, including :
  • FDA (e.g., 21 CFR 820)
  • ISO 13485 & ISO 9001
  • IEC (International Electrotechnical Commission) standards
  • CE Marking (European Conformity)
  • RoHS (Restriction of Hazardous Substances)
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    Principal Mechanical Engineer • Irvine, CA, US

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