Lead Process Engineer (Medical Device)

Location: Pleasant Prairie, Wisconsin

Step into a high-impact engineering role where you’ll shape the future of electro-mechanical medical device manufacturing. My client is seeking a driven expert to lead process innovation, ensuring products are reliable, compliant, and built to the highest standards. This is your chance to influence life-enhancing technology at scale.

Why You Should Apply

• Drive innovation in regulated medical device manufacturing
• High-visibility role with cross-functional leadership impact
• Hybrid work environment offering flexibility
• Opportunity to lead complex, high-value engineering initiatives
• Collaborate with top-tier engineering, quality, and regulatory teams
• Amazing bonuses and stellar benefit package
  
  

What You’ll Be Doing

• Lead manufacturing process improvements, validation, and optimization
• Implement new equipment, automation, and process expansions
• Troubleshoot complex production issues and drive root cause resolution
• Partner with suppliers, CMOs, and internal teams to ensure product quality
• Ensure compliance with FDA, ISO 13485, and global regulatory standards
• Manage documentation, ECOs, and support regulatory submissions
  
  

About You

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, Industrial, or Manufacturing)
• Strong expertise in process validation, statistical analysis, and quality systems
• Deep understanding of FDA Design Controls and/or CE Mark requirements
• Proven ability to lead complex engineering projects and process improvements
• Familiarity with electro-mechanical device manufacturing environments
  
  

How To Apply

Send your resume to kate@scientificsearch.com and reference Job #19833.