Sr Process Engineer

Scientific Search; Racine (WI); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Flexible work environment

Amazing bonuses

Comprehensive benefits package

Job summary

A leading recruitment agency is seeking a Sr. Process Engineer to lead process innovations in the manufacturing of electro-mechanical medical devices in Racine, Wisconsin. This high-impact role offers a hybrid work environment and the opportunity to manage complex engineering projects, ensuring product quality and compliance with FDA and ISO standards. The ideal candidate must have a Bachelor's degree in Engineering and strong knowledge of process validation and quality systems.

Qualifications

• Bachelor’s degree in Biomedical, Mechanical, Electrical, Industrial, or Manufacturing Engineering.
• Strong expertise in process validation, statistical analysis, and quality systems.
• Deep understanding of FDA Design Controls and/or CE Mark requirements.

Responsibilities

• 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.

Skills

Process validation

Statistical analysis

Quality systems

Engineering project leadership

Troubleshooting

Education

Bachelor’s degree in Engineering

Job description

Sr. Process Engineer

Location: Racine, 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 [e-mail] and reference Job #19833.