Electromechanical Assembly Process Engineer – Medical Devices

MPE Inc.; Milwaukee, Northern (WI, KY); Hybrid; USD 90,000 - 105,000; Full time

Job summary

MPE Inc. in Milwaukee, WI is seeking a Manufacturing Process Engineer for assembly to design, scale, and optimize electromechanical medical device assemblies in a low volume, high mix environment.

You will develop assembly processes, line layouts, tooling, and work instructions, establishing PFMEA-aligned controls and supporting design transfers, validation activities, CAPA, and continuous improvement. Candidates should have engineering experience with fixture design, CAD proficiency, and

Qualifications

• Bachelor’s degree in mechanical, Biomedical, Manufacturing, Industrial Engineering, or a related technical field.
• Minimum of 2 years of experience in a production environment focused on mechanical and electrical assemblies.
• Hands-on experience in fixture and tooling design, manufacturing process development, and full product builds.
• Proficient with SolidWorks, ProE, AutoCAD, or other CAD software.
• Experience using root cause and problem-solving methodologies (DMAIC, 5 Whys, Fishbone).
• Working knowledge of ISO 9001 & 13485 Quality System requirements.

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 to support product launches and design transfers.
• Support design prototype builds and full-line process validation activities (IQ/OQ/PQ).
• Drive process development and scale-up, including tools, fixtures, gauges and equipment fabrication.
• Lead interfaces with customers for manufacturing transfers and customer-specific requirements.
• Train and mentor assembly personnel and quality teams on defined processes.
• Manage multiple projects with shifting priorities and cross-functional collaboration for on-time delivery.
• Lead CAPA and deviation investigations and implement corrective actions.

Skills

Root cause analysis

GMP compliance

CAPA investigations

Continuous improvement

Problem solving

Education

Bachelor’s degree in mechanical, Biomedical, Manufacturing, Industrial Engineering

Associate degree in a technical discipline with related experience

Tools

SolidWorks

ProE

AutoCAD

Job description

MPE Inc. in Milwaukee, WI is seeking a Manufacturing Process Engineer for assembly to design, scale, and optimize electromechanical medical device assemblies in a low volume, high mix environment.

You will develop assembly processes, line layouts, tooling, and work instructions, establishing PFMEA-aligned controls and supporting design transfers, validation activities, CAPA, and continuous improvement. Candidates should have engineering experience with fixture design, CAD proficiency, and