Manufacturing Engineer Fabrication

MPE-Inc • Oak Creek, WI

4h • Hybrid

About The Position

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.

Requirements

• A degree in a technical field such as Mechanical, Manufacturing, or Industrial Engineering, or equivalent relevant experience.
• 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.
• Experience using root cause and problem-solving methodologies (DMAIC, 5 Whys, Fishbone, etc.).
• Working knowledge of ISO 9001 & 13485 Quality System requirements.
• Experience supporting continuous improvement initiatives.
• Proficiency in Microsoft Office Suite.

Nice To Haves

• 4i Blank and Form Programming Software, Influent and SigmaNest (preferred)
• Knowledge of FDA regulations is preferred.
• Six Sigma Green Belt or Black Belt certification (preferred).

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree