Title: Sr. Process Engineer – Medical Device
Location: Boulder, Colorado (Fully Onsite)
Type: W2 Contract
Duration: 2 years.
Key Skills Required:
• Validation expertise (IQ, OQ, PQ)
• Experience managing medium to large capital projects
• Knowledge of statistical methods and process control
• Manufacturing process development and optimization
• Medical device or regulated industry experience
• Equipment installation, qualification, and troubleshooting
• Cross-functional collaboration with R&D, Quality, and Manufacturing teams
• Project management and continuous improvement initiatives.
Role Summary:
Provide engineering support for electron beam manufacturing operations, ensuring efficient and compliant production processes. Lead equipment upgrades, process improvements, validations, and capital projects while maintaining quality, safety, and regulatory compliance. Collaborate with cross-functional teams to implement new technologies, troubleshoot complex systems, and drive operational excellence. Mentor junior engineers and support continuous improvement efforts in a fast-paced manufacturing environment.
Education & Experience:
• Bachelor's degree in Engineering or related field
• 4+ years of relevant experience (or 2+ years with an advanced degree)
• Experience in manufacturing and regulated environments preferred.