Senior Manufacturing Engineer – Product Transfer & Validation

Title: Sr Process Engineer

Location: Kalamazoo/Portage, MI

Pay Rate
: $40 per hour

• 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.

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.

Medical industry experience STRONGLY preferred.

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.

• 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