Staff Manufacturing Engineer, NPI

Stryker•Irvine, CA

7h•Onsite

About The Position

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.

Requirements

Four-year engineering degree or a technical discipline.
4 or more years’ experience in manufacturing engineering

Nice To Haves

MS, CQE, or CRE 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.

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.
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.