Fabrication Process Engineer II

MPE-Inc•Milwaukee, WI

About The Position

The manufacturing engineer for fabrication processes designs, scales, and optimizes metal fabrication and metalworking processes used in medical device assemblies to ensure consistent, high-quality production. The role develops fabrication programs and processes, including tooling and fixtures, and implements robust process controls aligned with PFMEA and GMP requirements in a low-volume, high-mix manufacturing environment. It serves as a technical liaison for customer design transfers, supports validation activities, and drives continuous improvement to enhance efficiency and reduce costs. The position also mentors and trains production personnel and serves as a subject matter expert in troubleshooting, CAPA, and GMP process compliance. The role defines, programs, and optimizes 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. It develops and maintains work instructions, process flows, handling and maintenance requirements, quality checklists, and technical drawings; establishes PFMEA-aligned process controls; defines ERP BOM structures; and develops GMP-compliant assembly documentation. It provides technical support during prototype builds, production, tooling, and process validation, including IQ/OQ/PQ as required. The engineer leads process development and scale-up, including the design, programming, program control, procurement, and fabrication of tools, fixtures, gauges, and equipment. It also manages tooling libraries and supports controlled, repeatable fabrication processes. As a technical lead for customer interfaces, the role supports product transfers, tolerance and manufacturability reviews, and implementation of customer-specific requirements. The engineer provides production support and trains and mentors fabrication personnel and quality teams.

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.
Experience with fabrication manufacturing processes such as laser cutting, turret punch, welding, hardware insertion, metal finishing, and/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, and Fishbone.
Working knowledge of ISO 9001 and ISO 13485 quality system requirements.
Experience supporting continuous improvement initiatives.
Proficiency in Microsoft Office Suite.
Ability to stand, sit, and walk for prolonged periods in office, manufacturing, warehouse, or operational environments.
Ability to occasionally bend, reach, climb stairs, and lift up to 40 pounds, if applicable.
Visual acuity to review data, analyze reports, and observe operational processes, with color perception required.
Strong analytical thinking and problem-solving abilities 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 with shifting priorities.
High attention to detail and strong organizational skills.
Effective communication skills, including presenting to customers and frontline teams.
Resilience and adaptability in dynamic operational settings, and the ability to receive and provide instructions positively.
Willingness to work across all locations and alter hours as needed to support projects and production.
Flexibility, integrity, and a can-do attitude.

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.
Convert 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 BOM structures and develop assembly documentation in compliance with GMP requirements.
Provide technical support and troubleshooting for prototype builds, production, tooling, and process validation activities, including IQ/OQ/PQ as required.
Drive process development and scale-up, including designing, programming, procuring, and fabricating tools, fixtures, gauges, and equipment.
Manage tooling libraries and support controlled, repeatable metal fabrication and metalworking processes.
Serve as a technical lead in customer interactions, supporting product transfers, tolerance and manufacturability reviews, and customer-specific requirements.
Train and mentor fabrication personnel and quality teams on established processes.
Support troubleshooting, CAPA, and GMP process compliance.
Support continuous improvement initiatives.