Stryker · 12 hours ago
Senior Staff R&D Electromechanical Process Development Engineer
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$116K/yr - $190K/yr
6+ years expStryker Inari is seeking a skilled R&D Development Engineer to support the scale-up and manufacturing readiness of an innovative electro-mechanical medical device. This role focuses on developing, optimizing, and validating robust manufacturing processes to ensure product quality, reliability, and regulatory compliance.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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
Qualification
Required
Bachelor's or Master's degree in Mechanical Engineering, Mechatronics, or Biomedical Engineering
6+ years of experience
Preferred
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
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (82)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chief Executive Officer
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase