Senior Staff R&D Development Engineer at Stryker

Irvine, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s or Master’s degree in Mechanical Engineering, Mechatronics, or Biomedical Engineering
6+ years of experience
Preferred Qualifications
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

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

Skills

Manufacturing Processes

Injection Molding

Precision Machining

Electro-Mechanical Assemblies

PFMEA

IQ/OQ/PQ

Root Cause Analysis

ISO 13485

FDA 21 CFR Part 820

Process Validation

Supplier Qualification

Design Transfer

Fixtures and Tools

Medical Device Development

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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