Process Engineer II

Responsibilities

• Own manufacturing processes to ensure stable, efficient, and compliant production in an FDA/ISO-regulated environment.
• 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.
• Develop and maintain manufacturing documentation (SOPs, work instructions, drawings, etc.), ensuring audit readiness and traceability.
• Lead process validation (IQ/OQ/PQ), PFMEA, and risk management to ensure robust and compliant processes.
• Partner with Quality to resolve nonconformances, drive CAPA to resolve issues and prevent recurrence.
• Support suppliers, including component/process qualification, issue resolution, and driving improvements in supplier quality and performance.
• Coordinate Engineering Change Notices (ECN) with managerial oversight for process & equipment changes and process impact of material changes.
• Ability to read and update CAD drawings, Solid Model assemblies, and machine schematics to troubleshoot problems and implement solutions.
• Perform additional duties as assigned by Manager.

Qualifications

• 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), etc.
• 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).