Scope of the role Regional – Irvine, CA Position summary This position independently leads complex activities and tasks in support of manufacturing operations. Activities and tasks are conducted on materials, products, processes, and equipment. Receives minimal direction /review and is viewed as an expert in one or more in-house technologies. Key areas of responsibility · Independently lead complex activities to design, document, and improve manufacturing processes and operations that control the safety and efficacy of components or finished devices. · Independently lead qualification, verification, and validation activities for the production of components or medical devices. · Analyze, troubleshoot, and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices. · Drive complex engineering work, new product development teams, and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, Six Sigma, process study, process improvements, and report preparation. Work is expected to broaden Stryker’s Intellectual Property in strategic areas. · Drive the design & development of manufacturing equipment in compliance with manufacturing safety (e.g., OSHA & EPA) principles. · Participate in design control efforts related to risk analysis (FMEA) & design reviews. · Preferred: Source component and service suppliers; assess supplier capability and effectiveness. · Lead efforts related to design, maintenance, and troubleshooting of controlled environment (facilities & equipment). · Train, mentor, and provide work direction to operators, technicians, and engineers. · Functional participant in post-market surveillance & annual product performance reviews. · Lead in the identification, implementation, and management of production goals. · Lead complex cross-functional project teams. Coordinate, manage, and document project goals and progress, and recommend appropriate revisions. · Design and coordinate complex engineering tests and experiments. Analyze data, draw conclusions, and summarize test results. Communicate results to the technical community. · Interfaces with product builders or extrusion technicians, production supervisors, and engineers in troubleshooting problems on the production floor. · Participates in project teams typically including one of the following: · Identifying and implementing process/product improvement alternatives to increase/optimize yield, efficiency, throughput, and/or performance. · Designing, performing, and documenting engineering test experiments to evaluate product/process performance. · Designing, developing, testing, and validating equipment and processes; analyzing and interpreting process models and recommending process improvements. · Evaluating external process technologies. · Identify and implement projects for cost savings. · Influence decisions around alternative engineering processes, products and equipment. · Coordinates with the appropriate suppliers and other external resources needed in developing and implementing process/product improvement plans. Education / work experience · Four-year engineering degree or a technical discipline. MS, CQE, or CRE preferred. · 4 or more years’ experience in manufacturing engineering, 5 years preferred. · 2 years medical products experience preferred. Knowledge / competencies · Ability to work well with others in a team setting. · Ability to conduct complex statistical, geometric, and mathematical calculations. · Ability to conduct responsibilities substantially free from routine supervision. · Ability to read, understand, create engineering drawings on common engineering software. · Ability to work efficiently on common personal computer hardware and software. · Proficient in Microsoft Office applications · Preferred: Proficient in use of Minitab, or similar, statistical software · Demonstrate a primary commitment to patient safety, product quality and compliance with the Stryker, Quality Manual and its governing regulations. · Ability to adopt & defend technical positions in an open and participative environment. · Demonstrated ability in forward looking perspective in relation to capacity & cost-control issues. · Demonstrated ability to effectively write and review technical documents & investigative reports. · Demonstrated project/task management skills. · Ability to mentor Engineers and other technical staff. 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. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.