Medical Device Process Validation Engineer

Rose International; Kalamazoo (MI); On-site; USD 85,000 - 120,000; Full time

Job summary

Rose International is seeking a Manufacturing Process Validation Engineer to support validation activities on manufacturing equipment and to document results in validation reports. The role collaborates with Quality, Operations, and Engineering to ensure compliance with regulatory requirements.

The candidate will assist with setting up components, fixtures, and tooling on the assembly line, troubleshoot production issues, and support continuous process improvements as products move into

Qualifications

• Manufacturing or process engineering experience, preferably within medical device manufacturing or another highly regulated industry.
• Hands-on ownership of equipment and process validation activities, including experimental runs, sample testing, operating data analysis, and formal validation report preparation.
• Strong experience developing and executing PPAP documentation, PFMEAs, Control Plans, SOPs, and process qualification packages for new product introductions or product transfers.
• Proven ability to analyze manufacturing equipment performance, troubleshoot equipment and assembly-line issues, and integrate tooling, fixtures, components, and test equipment into production.

Responsibilities

• 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.
• 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.

Skills

Manufacturing or process engineering

Equipment validation

PPAP documentation

PFMEAs

Education

Bachelor’s Degree

Job description

Rose International is seeking a Manufacturing Process Validation Engineer to support validation activities on manufacturing equipment and to document results in validation reports. The role collaborates with Quality, Operations, and Engineering to ensure compliance with regulatory requirements.

The candidate will assist with setting up components, fixtures, and tooling on the assembly line, troubleshoot production issues, and support continuous process improvements as products move into