Manufacturing Process Validation Engineer - Medical Devices

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

• 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.

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.

About Rose

• Founded in 1993
• Office Locations Across the U.S.
• 150+ Clients: Corporations and Government Agencies
• Employee Oriented Company
• Challenging Assignments Across the U.S.
• Continuous Professional Development

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