Manufacturing Process Engineer - Medical Device Assembly

MPE-Inc; Milwaukee (WI); On-site; USD 90,000 - 105,000; Full time

Job summary

MPE-Inc is seeking a Manufacturing Process Engineer - Assembly in Milwaukee, WI. You will design, scale, and optimize assembly operations for electromechanical medical device assemblies, creating robust processes and tooling in a low volume/high mix environment.

Responsibilities include leading process validation (IQ/OQ/PQ), CAD-driven tooling, and cross-functional collaboration to ensure on-time delivery while maintaining quality. Strong problem-solving and GMP compliance are essential.

Qualifications

• Minimum 2 years of experience in a production environment focused on mechanical and electrical assemblies.
• Proficient with engineering drawings, technical documentation and specifications.
• Experience with ISO 9001 & 13485 quality systems; FDA knowledge preferred.

Responsibilities

• Define and optimize assembly processes and line layouts for medical device electromechanical assemblies.
• Develop and maintain work instructions, process flows, handling and maintenance requirements, quality checklists and drawings.
• Establish PFMEA-aligned assembly process controls for launches and design transfers; define ERP BOM structures.
• Support design prototype builds and full-line process validation activities (IQ/OQ/PQ).
• Drive tooling design, procurement and fabrication for tools, fixtures, gauges and equipment.
• Lead interface with customers for manufacturing transfers and requirements.
• Train and mentor assembly personnel and quality teams.
• Manage multiple projects with shifting priorities and cross-functional collaboration.
• Lead CAPA and deviation investigations for manufacturing processes.

Skills

Power tools

Hand tools

Measurement instruments

Electrical testing equipment

Engineering drawings

CAD software

Root cause analysis

DMAIC / 5 Whys

ISO 9001 / 13485

Six Sigma

MS Office

Education

Bachelor's degree in Mechanical / Biomedical / Manufacturing / Industrial Engineering

Tools

SolidWorks

ProE

AutoCAD

Job description

MPE-Inc is seeking a Manufacturing Process Engineer - Assembly in Milwaukee, WI. You will design, scale, and optimize assembly operations for electromechanical medical device assemblies, creating robust processes and tooling in a low volume/high mix environment.

Responsibilities include leading process validation (IQ/OQ/PQ), CAD-driven tooling, and cross-functional collaboration to ensure on-time delivery while maintaining quality. Strong problem-solving and GMP compliance are essential.