Senior Process Engineer – NPI & Manufacturing Readiness

Stryker Group; Portage, Northern (MI, KY); Hybrid; USD 78,000 - 130,000; Full time

Job summary

Stryker's Advanced Operations (AO) team in Portage, MI is seeking a process engineer to support successful introduction of new products and manufacturing processes.

You will lead process engineering activities for launches and transfers, develop scalable manufacturing processes, validate, and ensure GMP and safety compliance while collaborating across functions.

The role emphasizes device manufacturing readiness, equipment qualification, and training of personnel during scale-up.

Qualifications

• Requires a Bachelor's degree in Mechanical Engineering or related field.
• 2+ years in manufacturing, process engineering, product development, or R&D.
• Experience with manufacturing processes, materials, product design, or process design.
• Ability to read and interpret engineering drawings and technical specifications.

Responsibilities

• Lead process engineering activities for new product introductions and transfers.
• Develop manufacturing processes that meet operational, material, and regulatory specs.
• Select manufacturing equipment and components based on requirements and standards.
• Develop and execute process validation activities (PFMEA, Control Plans, SOPs, PPAP, MSA).
• Analyze process and equipment performance using testing and statistics for continuous improvement.
• Lead or support capital equipment acquisition including installation and qualification.
• Review validation and quality documentation to ensure GMP compliance and safety.
• Train manufacturing personnel and provide technical guidance during launches and scale-up.

Skills

Process engineering

Engineering drawings reading

Data analysis

Education

Bachelor's degree in Mechanical Engineering or related Engineering

Job description

Stryker's Advanced Operations (AO) team in Portage, MI is seeking a process engineer to support successful introduction of new products and manufacturing processes.

You will lead process engineering activities for launches and transfers, develop scalable manufacturing processes, validate, and ensure GMP and safety compliance while collaborating across functions.

The role emphasizes device manufacturing readiness, equipment qualification, and training of personnel during scale-up.