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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.