Stryker · 15 hours ago
Staff Manufacturing Engineer, NPI
Irvine, California
Full-time
Onsite
Senior Level, Lead/Staff
4+ years expStryker Corporation is a leading medical technology company, and they are seeking a Staff Manufacturing Engineer to independently lead complex activities in support of manufacturing operations. The role involves designing, documenting, and improving manufacturing processes, as well as leading qualification and validation activities for medical devices.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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
Qualification
Required
Four-year engineering degree or a technical discipline
4 or more years' experience in manufacturing engineering
Preferred
2 years medical products experience
Ability to conduct complex statistical, geometric, and mathematical calculations
Ability to read, understand, create engineering drawings on common engineering software
Proficient in use of Minitab, or similar, statistical, and Microsoft Office software
Demonstrate a primary commitment to patient safety, product quality and compliance with the Stryker, Quality Manual and its governing regulations
Demonstrated ability in forward looking perspective in relation to capacity & cost-control issues
Demonstrated ability to effectively write and review technical documents & investigative reports
Ability to mentor Engineers and other technical staff
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 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase