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 9001IEC (International Electrotechnical Commission) standardsCE Marking (European Conformity)RoHS (Restriction of Hazardous Substances)