Validation Engineer

Genesis10 is currently seeking a Validation Engineer for a contract position with a Global Medical Technology Company located 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.

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

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

Desired skills:

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

Pay range:$51.00 - $61.00 per hour

Only candidates available and ready to work directly as Genesis10 employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, please apply!

Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.

For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10:

• 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)

For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.

Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.