Senior Staff R&D Process Development Engineer

Stryker-posted 12 days ago
Full-time • Senior
Onsite • Irvine, CA
5,001-10,000 employees
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Stryker Inari is seeking a skilled R&D Development Engineer to support the scale-up and manufacturing readiness of an innovative electro-mechanical medical device integrating precision components and injection-molded parts. This role focuses on developing, optimizing, and validating robust manufacturing processes to ensure product quality, reliability, and regulatory compliance. This role is fully onsite role in Irvine, CA with the expectation to be in office 5 days a week. Check out our product portfolio: Stryker Inari

  • Develop, optimize, and document manufacturing processes for electro-mechanical assemblies and injection-molded or precision-machined components.
  • Support design transfer from R&D to manufacturing, ensuring manufacturability and cost-effectiveness.
  • Create process flow diagrams, work instructions, PFMEAs, and validation protocols (IQ/OQ/PQ).
  • Collaborate with suppliers on injection molding, precision machining, and subassembly processes, including supplier qualification and capability assessment.
  • Design and implement fixtures, tools, and test setups to support assembly and inspection.
  • Conduct root cause analysis and implement corrective actions for process issues to improve yield, reliability, and throughput.
  • Ensure all processes comply with ISO 13485, FDA 21 CFR Part 820, and internal quality system requirements.
  • Contribute to documentation for regulatory submissions and manufacturing readiness.
  • Bachelor’s or Master’s degree in Mechanical Engineering, Mechatronics, or Biomedical Engineering.
  • 6+ years of experience
  • Process development or manufacturing engineering experience in the medical device industry, preferably in electro-mechanical or intelligent therapeutic systems (e.g., thrombectomy, cardiac, or neurovascular devices).
  • Proven experience developing and scaling complex electro-mechanical assemblies, including sub-systems involving motors, sensors, pumps, PCBs, firmware, and disposable interfaces.
  • Experience in medical system integration, especially involving console–catheter interfaces, sensor feedback loops, or closed-loop control systems.
  • Demonstrated success supporting new product introduction (NPI) and design transfer from R&D into pilot or full-scale production environments.
  • Strong knowledge of mechatronic system integration, including hardware–firmware interface validation, system calibration, and electro-mechanical testing.
  • Hands-on experience in process design, DOE, root cause analysis, SPC, and validation (IQ/OQ/PQ) of electromechanical manufacturing and test processes.
  • Familiarity with PCB and wiring assembly processes, electrical safety and EMC testing, and firmware programming workflows for embedded systems.
  • Proficiency with data acquisition, automation platforms (LabVIEW, PLC, or custom test systems), and firmware flashing/configuration processes during production.
  • Working knowledge of CAD tools (SolidWorks) for fixture and tooling design, as well as statistical analysis tools (Minitab, JMP) for process optimization.
  • Knowledge of firmware update validation, system calibration automation, or traceability tools in regulated environments.
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