Process Validation Engineer — Medical Devices

Energy Jobline ZR; Kalamazoo (MI); On-site; USD 70,000 - 120,000; Full time

Job summary

Energy Jobline ZR in Kalamazoo, MI is seeking an Equipment Validation Engineer to support process validation through sampling, data analysis, and documentation in validation reports. You will collaborate with Quality, Operations and Engineering to ensure processes meet requirements and to drive improvements as products move into production.

The role involves setting up and troubleshooting manufacturing equipment, participating in PPAP, PFMEA, and SOP activities, and ensuring GMP and safety

Qualifications

• Engineering degree with 4 years of experience in validation or manufacturing.
• Medical industry experience strongly preferred.
• PPAP, PFMEA, and Control Plan experience required.
• GMP and safety procedures knowledge essential.

Responsibilities

• Run samples on manufacturing equipment to support process validation and document results in validation reports.
• Collaborate with Quality, Operations and Engineering to ensure processes meet requirements and drive improvements.
• Set up components, fixtures, tooling, and equipment on the assembly line; troubleshoot during builds.
• Support PPAP activities, SOP development, and process qualification across product transfers.
• Assist materials team to ensure line readiness for components/materials and maintain cross-functional communication.

Skills

PPAP

Six Sigma

Statistical analysis

Process validation

Cross-functional collaboration

Education

Engineering degree

Tools

IQ/OQ/PQ documentation

PFMEA

Control Plan

Job description

Energy Jobline ZR in Kalamazoo, MI is seeking an Equipment Validation Engineer to support process validation through sampling, data analysis, and documentation in validation reports. You will collaborate with Quality, Operations and Engineering to ensure processes meet requirements and to drive improvements as products move into production.

The role involves setting up and troubleshooting manufacturing equipment, participating in PPAP, PFMEA, and SOP activities, and ensuring GMP and safety