Senior Process Engineer — Med Device Validation & Transfer

Comrise; Kalamazoo (MI); On-site; USD 95,000 - 135,000; Full time

Job summary

Comrise is seeking a Senior Process Engineer to support high-impact manufacturing and product transfer initiatives in a regulated medical device environment. The role emphasizes process validation, equipment integration, data analysis, troubleshooting, and continuous improvement to meet quality and safety standards.

The ideal candidate has hands-on experience with medical device manufacturing, equipment validation, and statistical methods for process development, collaborating closely with

Qualifications

• Bachelor's degree in Engineering or a related engineering discipline.
• At least 4 years of relevant engineering experience.
• Experience in the medical device industry is required.
• Hands-on experience with equipment and process validation.
• Knowledge of statistical methods used in process development and analysis.
• Experience integrating, troubleshooting, and supporting manufacturing or test equipment.
• Strong analytical, problem-solving, documentation, and cross-functional collaboration skills.
• Ability to work onsite in a manufacturing environment.

Responsibilities

• Execute process and equipment validation activities, including running samples on manufacturing equipment, collecting data, analyzing results, and preparing validation reports.
• Evaluate manufacturing and test equipment to establish operating parameters and verify process performance.
• Apply statistical methods to support process development, experimental testing, data analysis, and process optimization.
• Integrate, set up, and troubleshoot manufacturing and test equipment, fixtures, tooling, and assembly line components.
• Support product transfer initiatives by collaborating with cross-functional teams to ensure manufacturing processes are properly qualified and production-ready.
• Develop and maintain process documentation, including PFMEA, Control Plans, SOPs, PPAP documentation.
• Participate in process review meetings and contribute technical recommendations to resolve manufacturing challenges.
• Coordinate with Materials, Quality, Operations, and Engineering teams to ensure assembly lines are ready to receive components and raw materials.
• Identify opportunities for process improvement, cost transformation, and manufacturing efficiency.
• Ensure compliance with GMP, quality standards, and safety procedures.

Job description

Comrise is seeking a Senior Process Engineer to support high-impact manufacturing and product transfer initiatives in a regulated medical device environment. The role emphasizes process validation, equipment integration, data analysis, troubleshooting, and continuous improvement to meet quality and safety standards.

The ideal candidate has hands-on experience with medical device manufacturing, equipment validation, and statistical methods for process development, collaborating closely with