Senior Manufacturing Engineer – Product Transfer & Validation

Kelly Science, Engineering, Technology & Telecom; Kalamazoo (MI); On-site; USD 70,000 - 95,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

GMP compliance

Statistical methods

Equipment integration

PPAP

Six Sigma

Education

Engineering degree

Job description

Title: Sr Process Engineer

Location: Kalamazoo/Portage, MI

Pay Rate: $40 per hour

Schedule

• M-F / on-site.
• Core hours: Start between 6–8 AM EST and end between 3–5 PM EST, with potential for 1–2 hours of overtime per week.

This role would spend much of the day supporting process validation activities by running samples on manufacturing equipment, collecting and analyzing data, and documenting results in validation reports. They would work closely with Quality, Operations, and Engineering teams to ensure processes meet requirements. In addition, they would help set up components, fixtures, tooling, and equipment on the assembly line, troubleshoot issues during builds, and support process improvements as products move into production. Assist and collaborate with the Materials team to make sure the line is set up to receive components/raw materials. Overall, the position combines hands‑on manufacturing support with technical documentation and cross‑functional collaboration.

Responsibilities

The role contributes to the delivery of high-impact, cost-transformative projects. The role will require the successful candidate to operate across a network of stakeholders from Product Transfer, Operations, and Divisional partners; therefore, strong interpersonal skills and communication skills will be necessary. The position will require PPAP skills, analysis of equipment to establish operating data, and experimental testing and results analysis. May lead or act as an independent reviewer in process review meetings. Participate in PFMEA, Control Plan, SOP, PPAP, and other Stryker internal process qualification generation associated with product transfers.

The ideal candidate will have the following skills:

• Ensure adherence to GMP and safety procedures.
• Statistical methods for process development.
• Manufacturing/test equipment integration and troubleshooting.
• PPAP experience, ability to manage a workstream and its tasks, complex problem-solving, Six Sigma/continuous improvement.
• Engineering degree, 4 years of experience.

Nice to have:

Medical industry experience STRONGLY preferred.

All recap

The project is approximately two years into a three-year timeline, with the team targeting a July/August launch next year. Current activities are focused on validating equipment already installed on the manufacturing floor. A six-piece engineering build is starting, with the V&V build planned for December or early January.

The contractor will primarily support equipment validation, including torque screw applications and other specialized equipment. Additional responsibilities include IQ/OQ/PQ documentation, work instructions, PPAP support, process planning, material labeling, hand-tool setup, and equipment troubleshooting/integration.

Key takeaways

• Top skills: Equipment validation, statistical methods/process development, and equipment troubleshooting/integration.
• Work split: Currently about 50% hands‑on / 50% documentation. After V&V, the role will become more documentation-focused, approximately 70% documentation / 30% hands‑on.
• Location: 100% on-site in the Kalamazoo/Portage, Michigan area