Senior Process Engineer - Medical Device Validation & CI

Matlen Silver; Kalamazoo (MI); On-site; USD 54,000 - 59,000; Full time

Job summary

Matlen Silver is seeking a Sr Process Engineer in Portage, MI for a 6-month engagement with potential extension. The role focuses on process validation, data collection and analysis, and cross‑functional support across Quality, Operations and Engineering.

The successful candidate will help set up line components and tooling, troubleshoot during builds, and collaborate with the materials team to ensure material readiness. Requires medical industry experience and USC/GC eligibility.

Qualifications

• Engineering degree required and 4 years of experience.
• Medical industry experience is required.

Responsibilities

• Support process validation activities by running samples on manufacturing equipment and documenting results.
• Collaborate with Quality, Operations and Engineering to ensure processes meet requirements.
• Assist in setting up components, fixtures, tooling and equipment on the assembly line and troubleshoot during builds.
• Collaborate with materials team to ensure line readiness for components and raw materials.
• Participate in PFMEA, Control Plan, SOP and PPAP activities related to product transfers.
• Ensure adherence to GMP and safety procedures.
• Apply statistical methods for process development and data analysis.
• Integrate and troubleshoot manufacturing/test equipment and processes.
• Lead or act as independent reviewer in process reviews.

Skills

PPAP skills

Six Sigma

Data analysis

Cross-functional collaboration

Education

Engineering degree

Job description

Matlen Silver is seeking a Sr Process Engineer in Portage, MI for a 6-month engagement with potential extension. The role focuses on process validation, data collection and analysis, and cross‑functional support across Quality, Operations and Engineering.

The successful candidate will help set up line components and tooling, troubleshoot during builds, and collaborate with the materials team to ensure material readiness. Requires medical industry experience and USC/GC eligibility.