Process Engineer II

The Process Engineer II will provide process engineering support for the Machine Shop and act as a backup to any/all other manufacturing departments. They will support manufacturing operations to ensure consistent adherence to the standard operating procedures and business continuity. The Process Engineer II will initiate process improvement initiatives to improve the efficiency of current manufacturing processes and develop new processes to improve manufacturing efficiency.

What You Will Do

The Process Engineer II will own manufacturing processes to ensure stable, efficient, and compliant production in an FDA/ISO-regulated environment. They will provide production support by troubleshooting processes and equipment, performing root cause analysis, and delivering technical leadership and training to production teams to ensure effective execution and sustainment.

Why It Might Be a Fit

The Process Engineer II will lead process validation (IQ/OQ/PQ), PFMEA, and risk management to ensure robust and compliant processes. They will partner with Quality to resolve nonconformances, drive CAPA to resolve issues and prevent recurrence. The Process Engineer II will provide technical ownership for suppliers, including component/process qualification, issue resolution, and driving improvements in supplier quality and performance.

Requirements

• Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or related field of engineering)
• 2-5 years of medical device, tissue product, or related engineering experience (1-3 years with Masters in Engineering)
• Data-Driven Problem Solving: Demonstrated understanding of problem-solving tools including; root cause analysis (5-why, fishbone) and Statistical process control (SPC)
• Process Optimization / Lean Mfg.: Demonstrated execution of lean principles, cycle time / throughput improvement, yield improvement, workflow optimization, etc.
• Cross-Functional Collaboration: ability to work cross-functionally with operators, quality, regulatory and management teams; train operators and implement new processes, etc.
• CNC / Machining Knowledge: basic understanding of CNC milling, turning, lathes, lapping, multi-axis machining, etc. is preferred
• CAD/CAM & Programming Proficiency: basic understanding of CAM Software (Mastercam), how to generate/optimize toolpaths, and machine code (G-code)

Benefits

• Comprehensive Medical, Dental, and Vision
• Life Insurance
• Supplemental Benefits
• 401(k) with both Traditional and Roth options available
• Employee Stock Purchase Plan (ESPP)
• 10 Paid Company Holidays
• Competitive PTO plan
• Tuition Reimbursement