Staff Manufacturing Engineer

Stryker is seeking a Staff Engineer to join our Peripheral Vascular (PV) team. In this role, you will serve as a Technical Lead, driving engineering initiatives across both manufacturing and research & development (R&D) functions. This is an onsite position in Irvine, CA.

What you will do-

• ⁠Lead complex manufacturing process design and improvement activities to ensure the safety and efficacy of components and finished medical devices

• Independently lead qualification, verification, and validation (QVV) of manufacturing processes, equipment, and product lines for medical device production

• Troubleshoot and resolve issues related to product safety, quality, cost, delivery, and process performance

• Drive engineering initiatives and new product development, including technology development, process studies, Six Sigma projects, materials testing, and intellectual property generation

• Design and develop manufacturing equipment in compliance with safety regulations such as OSHA and EPA standards

• Participate in design control efforts, including risk analysis (FMEA), design reviews, and validation protocols

• Lead supplier sourcing and evaluation efforts to assess capability, quality, and effectiveness of external partners and service providers

• Direct controlled environment operations, including cleanroom design, equipment maintenance, and troubleshooting

• Mentor and train cross-functional teams, including engineers, technicians, and operators, while also supporting post-market surveillance and product performance reviews

• Lead and coordinate cross-functional project teams, manage timelines, define goals, evaluate engineering tests and experiments, and identify opportunities for process optimization and cost savings

What you need- 

• Bachelor's degree in engineering or related technical field - required

• 4+ years of relevant experience - required

• Ability to conduct complex statistical, geometric, and mathematical calculations

• Ability to read, understand, create engineering drawings on common engineering software

• Ability to mentor Engineers and other technical staff

• Proficient in use of Minitab, or similar, statistical software - preferred

$102,700 - $171,100 USD Annual