Position Objective:
Responsible for providing process engineering support for the Machine Shop and act as a backup to any/all other manufacturing departments. Supports manufacturing operations to ensure consistent adherence to the standard operating procedures and business continuity. Initiates process improvement initiatives to improve the efficiency of current manufacturing processes, as well as developing new processes to improve manufacturing efficiency. Supports new product launches by collaborating with other functional areas and providing process engineering expertise during the implementation of processes or equipment.
Responsibilities:
Process Engineering Support:- 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
- Provide technical ownership for 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.
Continuous improvement:- Identify improvement opportunities through data analysis, operator feedback, and observation; implement data-driven improvements to enhance yield, throughput, and uptime.
- Monitor and improve performance using SPC and capability analysis (Cp/Cpk); establish and maintain process control limits.
New Process/Product Implementation:- Support equipment and tooling selection, qualification, and implementation, including automation where applicable.
- Lead design transfer and new product introduction (NPI), ensuring manufacturability, scalability, and alignment between R&D and operations.
- Provides engineering support for new equipment start-up, debug and process validation. As required, conducts process evaluations and validations under guidance of senior engineers and quality engineering.
Other responsibilities as assigned.
Qualifications:
Required:- 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 Typically requires 2-5 years of medical device, tissue product or related engineering experience (1-3 years with Masters in Engineering).
- 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.
Required:- 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
