Medical Device Fabrication Process Engineer II

MPE-Inc; Milwaukee (WI); On-site; USD 81,000 - 99,000; Full time

Job summary

MPE-Inc in Milwaukee, WI is hiring a Fabrication Process Engineer II to design, scale, and optimize metal fabrication and machining for medical device assemblies. You will create tooling, fixtures, and process controls aligned with GMP and PFMEA, while partnering on design transfers and continuous improvement.

The role requires a technical degree and at least 2 years in fabrication workflows, with CAD software proficiency and knowledge of quality systems; Six Sigma certification is a plus.

Qualifications

• A degree in Mechanical, Manufacturing, or Industrial Engineering, or equivalent relevant experience.
• Minimum of 2 years of experience in fabrication/manufacturing processes such as laser cutting, turret punch, welding, hardware insertion, metal finishing, or press brake.
• Proficiency with CAD software (SolidWorks, ProE, AutoCAD) and measurement tools.
• Knowledge of ISO 9001 & 13485 quality systems; FDA regulation knowledge preferred.
• Six Sigma Green Belt or Black Belt certification preferred.

Responsibilities

• Define, program, and optimize metal fabrication and machining processes for medical device assemblies.
• Develop work instructions, process flows, and QA checklists in GMP-compliant environment.
• Establish PFMEA-aligned process controls and BOM structures for product launches.
• Provide technical support during prototyping, validation, and production, including IQ/OQ/PQ.
• Lead tooling design, fixtures, gauges, and equipment for controlled fabrication processes.
• Assist in customer design transfers and supplier interactions as needed.

Skills

Problem-solving

Cross-functional liaison

Analytical thinking

Process optimization

Quality awareness

Education

Mechanical/Manufacturing/Industrial Engineering degree

Tools

SolidWorks

Pro/Engineer

AutoCAD

SigmaNest

4i Blank & Form Programming

DMAIC/5 Whys/Fishbone

Microsoft Office

Job description

MPE-Inc in Milwaukee, WI is hiring a Fabrication Process Engineer II to design, scale, and optimize metal fabrication and machining for medical device assemblies. You will create tooling, fixtures, and process controls aligned with GMP and PFMEA, while partnering on design transfers and continuous improvement.

The role requires a technical degree and at least 2 years in fabrication workflows, with CAD software proficiency and knowledge of quality systems; Six Sigma certification is a plus.