Fabrication Process Engineer II

Job Summary:

The manufacturing engineer for fabrication processes is responsible for designing, scaling, and optimizing metal fabrication and metalworking processes used within medical device assemblies to ensure consistent, high-quality production. Develops fabrication programs and processes, including tooling and fixtures, while implementing robust process controls aligned with PFMEA and GMP requirements in a low-volume, high-mix manufacturing environment. Serves as a technical liaison for customer design transfers, supports validation activities, and drives continuous improvement initiatives to enhance efficiency and reduce costs. Provides mentoring and training to production personnel, and acts as a subject matter expert in troubleshooting, CAPA, and GMP process compliance.

Essential Duties and Responsibilities:

• Define, program, and optimize metal fabrication and machining processes for fabricated subassemblies that will be used in medical device electro-mechanical 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, while identifying opportunities to improve efficiency, throughput and overall process capability.
• Establish and maintain PFMEA-aligned assembly process controls to support successful product launches and design transfers. Define ERP BOM 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 efforts, including the design, programming and program control, procurement and fabrication of tools, tooling library management fixtures, gauges, and equipment to enable controlled, repeatable metal fabrication and metalworking fabrication processes.
• Serve as a technical lead when interfacing with customers, supporting product transfer efforts, tolerance and manufacturability reviews, and the implementation of customer-specific requirements.
• Provide technical support to production including training and mentoring fabrication personnel and quality teams on established processes.

Education

• A degree in a technical field such as Mechanical, Manufacturing, or Industrial Engineering, or equivalent relevant experience.

Experience and/or Training

• Minimum of 2 years of experience, or an equivalent combination of education and relevant fabrication manufacturing experience in fabrication manufacturing processes such as laser cutting, turret punch, welding, hardware insertion, metal finishing, and/or press brake, etc.
• Proficient with SolidWorks, ProE, AutoCAD, or other CAD software.
• Proficient in power tools, hand tools, precision measurement instruments.
• Proficient in interpreting and creating engineering drawings, technical documentation, and specifications.
• Proficient with SolidWorks, ProE, AutoCAD, or other CAD software.
• 4i Blank and Form Programming Software, Influent and SigmaNest (preferred)
• Experience using root cause and problem-solving methodologies (DMAIC, 5 Whys, Fishbone, etc.).
• Working knowledge of ISO 9001 & 13485 Quality System requirements.
• Knowledge of FDA regulations is preferred.
• Experience supporting continuous improvement initiatives.
• Six Sigma Green Belt or Black Belt certification (preferred).
• Proficiency in Microsoft Office Suite.

Physical and Mental Demands

• Frequent prolonged standing and sitting standing and walking in office, manufacturing, warehouse, or operational environments.
• Occasional bending, reaching, climbing stairs, and light lifting (up to 40 lbs., if applicable).
• Visual acuity to review data, analyze reports, and observe operational processes, with color perception required.
• High level of analytical thinking and problem-solving to evaluate complex processes and identify root causes.
• Ability to interpret data, metrics, and financial impact analyses to drive decisions.
• Ability to manage multiple projects simultaneously with shifting priorities.
• High attention to detail with strong organizational skills.
• Effective communication skills, including presenting to customers and frontline teams.
• Resilience and adaptability in dynamic operational settings.
• Ability to receive and provide instructions in a positive manner.
• Willing to work across all locations and alter hours as to ensure continuous support for projects and production as needed.
• Flexible to change and possess a high degree level of integrity and “can do attitude”.

Work Environment

• Primarily office-based work with frequent presence in a production environment. While in the production facility, exposure to moderate to loud noise levels and non-climate-controlled conditions may occur.