Fabrication Process Engineer II
About The Position
The Fabrication Process Engineer II designs, scales, and optimizes metal fabrication and metalworking processes used in medical device assemblies to support consistent, high-quality production in a low-volume, high-mix manufacturing environment. The role develops fabrication programs and processes, including tooling and fixtures, and implements robust process controls aligned with PFMEA and GMP requirements. The engineer supports customer design transfers, prototype builds, production, tooling, and process validation activities, including IQ/OQ/PQ as required. The role also drives process development, scale-up, and continuous improvement to improve efficiency, throughput, process capability, and cost. As a technical subject matter expert, the engineer troubleshoots issues, supports CAPA and GMP compliance, and trains and mentors production and quality personnel. Work is primarily office-based, with frequent presence in production environments. Production-area exposure may include moderate to loud noise and non-climate-controlled conditions. The position may require work across all locations and altered hours to support projects and production as needed.
Requirements
- A degree in a technical field such as Mechanical, Manufacturing, or Industrial Engineering, or equivalent relevant experience.
- At least 2 years of experience, or an equivalent combination of education and relevant fabrication manufacturing experience, in processes such as laser cutting, turret punch, welding, hardware insertion, metal finishing, or press brake.
- Proficiency with SolidWorks, ProE, AutoCAD, or other CAD software.
- Proficiency with power tools, hand tools, and precision measurement instruments.
- Proficiency in interpreting and creating engineering drawings, technical documentation, and specifications.
- Experience using root-cause and problem-solving methodologies such as DMAIC, 5 Whys, or Fishbone.
- Working knowledge of ISO 9001 and ISO 13485 quality system requirements.
- Experience supporting continuous improvement initiatives.
- Proficiency in Microsoft Office Suite.
- Ability to work across all locations and alter hours as needed to provide continuous support for projects and production.
- Ability to manage multiple projects with shifting priorities, communicate effectively, maintain strong attention to detail, and adapt to dynamic operational settings.
Nice To Haves
- Experience with 4i Blank and Form Programming Software, Influent, and SigmaNest.
- Knowledge of FDA regulations.
- Six Sigma Green Belt or Black Belt certification.
Responsibilities
- Define, program, and optimize metal fabrication and machining processes for fabricated subassemblies used in medical device electromechanical assemblies, including converting 3D models and drawings into flat patterns with appropriate bend deductions and allowances.
- Develop and maintain work instructions, process flows, handling and maintenance requirements, quality checklists, and technical drawings; identify opportunities to improve efficiency, throughput, and process capability.
- Establish and maintain PFMEA-aligned assembly process controls for product launches and design transfers.
- Define ERP bill-of-material structures and develop assembly documentation in compliance with GMP requirements.
- Provide technical support and troubleshooting during prototype builds, production, tooling, and process validation activities, including IQ/OQ/PQ as required.
- Drive process development and scale-up, including designing and programming processes; controlling programs; procuring and fabricating tools; managing tooling libraries; and developing fixtures, gauges, and equipment for controlled, repeatable fabrication and metalworking.
- Serve as a technical lead when interfacing with customers, supporting product transfers, tolerance and manufacturability reviews, and implementation of customer-specific requirements.
- Train and mentor fabrication personnel and quality teams on established processes.
- Support troubleshooting, CAPA, GMP process compliance, and continuous improvement initiatives.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
