Date Posted: 10/12/2026
Hiring Organization: Rose International
Position Number: 509041
Industry: Medical Equipment & Supplies
Job Title: Manufacturing Process Validation Engineer - Medical Devices
Job Location: Kalamazoo, MI, USA, 49005
Work Model: Onsite
Shift: 8 AM - 5 PM Mon - Fri
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 13
Min Hourly Rate($): 55.00
Max Hourly Rate($): 60.00
Must Have Skills/Attributes: Engineering, Manufacturing, Troubleshooting
Experience Desired:
Manufacturing or process engineering experience (4+ yrs),
Hands-on ownership of equipment and process validation activities (4+ yrs),
Strong experience developing and executing PPAP documentation (4+ yrs),
Proven ability to analyze manufacturing equipment performance, troubleshoot equipment and assembly-line issues (4+ yrs)
Required Minimum Education: Bachelor’s Degree
**C2C is not available**
Job Description
Required Education:
• Bachelor’s Degree
Required Skills:
• 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.
Overview:
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 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
Manufacturing Process Validation Engineer - Medical Devices:
• 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.
• Position will require PPAP skills, analyze equipment to establish operating data, conduct experimental test and result analysis.
• May lead or act as independent reviewer in process review meetings.
• Participate in PFMEA, Control Plan, SOP, PPAP and other Stryker internal process qualification generation associated with product transfers.
• Ensure adherence to GMP and safety procedures.
• Equipment Validation Experience.
• Statistical methods for process development.
• Manufacturing/Test Equipment Integration & Troubleshooting
• PPAP experience, ability to manage a workstream and its tasks, Complex problem solving,Six Sigma/continuous improvement
- **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
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