MedTech Process Development Engineer - GMP & PFMEA Lead

Stryker; Kalamazoo (MI); Presencial; USD 78.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

HSA

FSAs

401(k) plan

Employee Stock Purchase Plan (ESPP)

Life and AD&D insurance

Short-term disability

Wellbeing program

Descripción de la vacante

Stryker, a leading medical technology company, seeks a Senior Engineer, Process Development to join its OrthoTech Division in Portage, MI. This onsite role emphasizes new product introductions, process development, and GMP compliance, partnering with design and manufacturing teams to drive quality and efficiency.

Responsibilities include PFMEA, DOE studies, equipment validation, capital projects, and training manufacturing personnel, with travel to sites as needed.

Formación

• Bachelor's degree in engineering required.
• 2+ years of full-time work experience required.
• PFMEA experience required.
• Ability to read and interpret GD&T drawings.
• Strong documentation and cross-functional communication skills.
• Willingness to travel between sites.

Responsabilidades

• Support new product and process introductions, ensuring activities are documented per NPD procedures.
• Ensure quality of process and product.
• Support supply chain architecture and implementation to meet project needs.
• Own process development and validation for the entire supply chain.
• Communicate DFM, DFA, and DFI considerations with designers and suppliers.
• Lead/select components based on specs, reliability and regulatory requirements.
• Develop testing and inspection equipment and protocols.
• Lead capital acquisition: equipment specs, contracts, installation and validation.
• Analyze equipment data, conduct tests and result analysis; participate in reviews.
• Own PFMEA/PCP and validation planning/execution per quality system.
• Complete DOE, MSA, capability studies for component and assembly processes.
• Provide training for manufacturing teams.
• Ensure adherence to GMP and safety procedures.

Conocimientos

PFMEA knowledge

GD&T interpretation

Cross-functional communication

Analytical skills

Engineering documentation

Machining/manufacturing knowledge

Reading engineering drawings

Travel willingness

Educación

Bachelor's degree in engineering

Herramientas

CAD

Descripción del empleo

Stryker, a leading medical technology company, seeks a Senior Engineer, Process Development to join its OrthoTech Division in Portage, MI. This onsite role emphasizes new product introductions, process development, and GMP compliance, partnering with design and manufacturing teams to drive quality and efficiency.

Responsibilities include PFMEA, DOE studies, equipment validation, capital projects, and training manufacturing personnel, with travel to sites as needed.