Senior Process Engineer - Onsite Medical Device Validation

Ultimate Staffing; Kalamazoo (MI); On-site; USD 68,000 - 97,000; Full time

Job summary

Ultimate Staffing is seeking a Senior Process Engineer for an onsite role in Kalamazoo, MI. The position involves validating processes, running samples on manufacturing equipment, collecting data, and documenting results in validation reports while collaborating with Quality, Operations and Engineering to ensure GMP-compliant production.

You will help set up components, fixtures, tooling and equipment on the assembly line, troubleshoot issues during builds, and support process improvements as

Qualifications

• Engineering degree required with 4+ years of experience.
• PPAP, PFMEA, and Control Plan experience.
• GMP and safety procedures in medical device environment.
• Strong cross-functional collaboration and communication skills.
• Six Sigma/continuous improvement experience.

Responsibilities

• Validate processes by running samples and analyzing data.
• Document results in validation reports and coordinate with QA/Operations/Engineering.
• Set up components, fixtures, tooling, and equipment on the line.
• Troubleshoot manufacturing during builds and support production transfers.
• Lead or review process qualification activities including PPAP.

Skills

Equipment Validation

Statistical methods

Equipment integration

PPAP

Six Sigma

Education

Engineering degree

Job description

Ultimate Staffing is seeking a Senior Process Engineer for an onsite role in Kalamazoo, MI. The position involves validating processes, running samples on manufacturing equipment, collecting data, and documenting results in validation reports while collaborating with Quality, Operations and Engineering to ensure GMP-compliant production.

You will help set up components, fixtures, tooling and equipment on the assembly line, troubleshoot issues during builds, and support process improvements as