Validation Engineer

Genesis10 • Kalamazoo, MI

12d • $51 - $61 • Onsite

About The Position

Genesis10 is seeking a Validation Engineer for a contract position with a Global Medical Technology Company in Kalamazoo, MI. This is a 12+ month contract opportunity. This role supports process validation activities by running samples on manufacturing equipment, collecting and analyzing data, and documenting results. The successful candidate will work closely with Quality, Operations, and Engineering teams to ensure manufacturing processes meet all requirements and support process improvements as products move into production.

Requirements

• Engineering degree
• 4+ years of relevant experience
• Experience with equipment validation
• Experience with statistical methods for process development
• Knowledge of manufacturing/test equipment integration and troubleshooting
• PPAP experience
• Strong interpersonal, communication, and complex problem-solving skills

Nice To Haves

• Experience in the medical device industry or a related regulated industry
• Six Sigma/continuous improvement experience
• Ability to manage a workstream and its tasks

Responsibilities

• Support process validation activities by running samples on manufacturing equipment, collecting and analyzing data, and documenting results in validation reports
• Work closely with Quality, Operations, and Engineering teams to ensure processes meet requirements
• Set up components, fixtures, tooling, and equipment on the assembly line
• Troubleshoot issues during builds and support process improvements as products move into production
• Collaborate with the materials team to ensure the line is set up to receive components and raw materials
• Participate in PFMEA, Control Plan, SOP, PPAP, and other internal process qualification generation
• Ensure adherence to GMP and safety procedures

Benefits

• Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years.
• The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
• Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)
• Behavioral Health Platform
• Medical, Dental, Vision
• Health Savings Account
• Voluntary Hospital Indemnity (Critical Illness & Accident)
• Voluntary Term Life Insurance
• 401K
• Sick Pay (for applicable states/municipalities)
• Commuter Benefits (Dallas, NYC, SF, and Illinois)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level