Manufacturing Engineer, NPI

Staff Manufacturing Engineer, NPI page is loaded## Staff Manufacturing Engineer, NPIlocations:
Irvine, California time type:
Full time posted on:
Posted Todayjob requisition :
R558048

Work Flexibility:
Onsite
** 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.

*
* Minimum Requirements:

*** Four-year engineering degree or a technical discipline. MS, CQE, or CRE preferred.
* 4 or more years’ experience in manufacturing engineering
** Preferred

Skills:

*** 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.
*…