PI-658 | Process Engineer, Advanced Operations

PI-658 | Process Engineer, Advanced Operations

17 mar
Stryker Corporation

17 mar

Stryker Corporation


Who We Want

- Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

- Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

- Motivated product launchers.

People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What You Will Do

- Provide engineering support for Manufacturing transfers and / or new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.

- Ensure quality of process and product as defined in the appropriate operation and material specifications.

- Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements.

- Support capital acquisition activities.

- Will analyze equipment to establish operating data, conduct experimental test and result analysis. Participate in process review meetings.

- Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.

- Complete capability studies for in process inspection and generate subsequent Inspection documentation.

- Conduct MSA studies for new products and new processes.

- Provide training for manufacturing team members.

- Ensure adherence to GMP and safety procedures.

- All other duties as assigned.

What You Will Need

- Bachelor’s degree in an engineering discipline

- 4+ years of experience in a technical or project management role

- Will have demonstrated an ability to define project risk and to effectively manage project risks

- Demonstrated experience with Microsoft products - Excel, Access, PowerPoint, MS Project required

- Excellent attention to detail and interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams

- The individual should enjoy working in a dynamic & results oriented team environment where flexibility is essential

- Excellent analytical skills, ability to plan, organize and implement concurrent tasks

- Demonstrated Leadership, Project Management and Engineering experience in New Product Introduction in a regulated environment

- Experience in an FDA regulated or regulated industry

- Experience of GD&T;, process mapping, statistical methods and process/product validations

- Bilingual: English & Spanish


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