Lead Manufacturing Engineer – Product Transfer & Validation

Kelly Science, Engineering, Technology & Telecom; Kalamazoo (MI); Presencial; USD 70.000 - 95.000; Jornada completa

Descripción de la vacante

Stryker is seeking a Sr Process Engineer to support equipment validation on the Kalamazoo site. You will run samples, analyze data, and document results to ensure processes meet requirements, while collaborating with Quality, Operations, and Engineering teams.

The role involves setting up line equipment, troubleshooting during builds, and supporting PPAP, PFMEA, and control plans as products transfer into production. On-site with strong emphasis on GMP and data-driven improvements.

Formación

• GMP compliance knowledge and safety procedures are required.
• Strong grasp of statistical methods for process development.
• Experience with manufacturing/test equipment integration and troubleshooting.
• PPAP knowledge and experience in managing a workstream.
• Six Sigma or continuous improvement experience is a plus.

Responsabilidades

• Support process validation activities by running samples and collecting data.
• Document results in validation reports and collaborate with Quality, Operations, and Engineering.
• Assist setup of components, fixtures, and equipment on the assembly line and troubleshoot issues.
• Contribute to process improvements as products move into production and participate in PFMEA, Control Plan, SOP, and PPAP.

Conocimientos

GMP compliance

Statistical methods

Equipment integration

PPAP

Six Sigma

Educación

Engineering degree

Descripción del empleo

Stryker is seeking a Sr Process Engineer to support equipment validation on the Kalamazoo site. You will run samples, analyze data, and document results to ensure processes meet requirements, while collaborating with Quality, Operations, and Engineering teams.

The role involves setting up line equipment, troubleshooting during builds, and supporting PPAP, PFMEA, and control plans as products transfer into production. On-site with strong emphasis on GMP and data-driven improvements.