Manufacturing Engineer Assembly
MPE-Inc
Job Description
Job Description
At MPE, we're dedicated to making a difference in the world through cutting-edge medical technology. Our mission is to be the global leader in design, engineering, and manufacturing solutions for the medical and technology industries — creating impactful solutions that improve lives, and fostering an environment where our team members can thrive, grow, and contribute to groundbreaking advancements in the medical field.
A better career for you. Creating medical technology for all.
Why This RoleAs our Manufacturing Engineer, Assembly, you'll design and optimize the assembly processes behind electromechanical medical device products — from line layout and tooling to full-scale process validation. You'll work in a low-volume, high-mix environment, which means real variety: new builds, new challenges, and new problems to solve on a regular basis, rather than optimizing the same line indefinitely.
This role also puts you in front of customers directly — as a technical liaison during manufacturing transfers — and gives you real ownership over process development, from initial design through launch. If you want engineering work that's tied directly to medical technology that improves people's lives, this is that role.
What You'll DoProcess & Line Design
- Define and optimize assembly processes and line layouts for electromechanical medical device assemblies
- Design, procure, and help fabricate the tools, fixtures, gauges, and equipment needed for controlled, repeatable assembly
- Develop and maintain work instructions, process flows, quality checklists, and technical drawings, continually identifying opportunities to improve efficiency and throughput
Process Controls & Documentation
- Establish PFMEA-aligned process controls to support successful product launches and design transfers
- Define ERP BOM structures and develop assembly documentation aligned with GMP requirements
Validation & Troubleshooting
- Support prototype builds and full-line process validation activities, including IQ/OQ/PQ as required
- Serve as subject matter expert in CAPA and deviation investigations, using root cause analysis and error-proofing techniques to implement sustainable corrective actions
Customer & Team Leadership
- Serve as technical lead when interfacing with customers during manufacturing transfers and implementation of customer-specific requirements
- Train and mentor assembly and quality personnel on established processes
- Manage multiple projects simultaneously, adapting to shifting priorities while keeping cross-functional partners updated
Required
- Bachelor's degree in Mechanical, Biomedical, Manufacturing, Industrial Engineering, or a related technical field — or an associate's degree in a technical discipline combined with relevant experience
- 2+ years of experience in a production environment focused on mechanical and electrical assemblies, including hands-on fixture/tooling design, process development, and assembly line operations
- Proficiency with CAD software (SolidWorks, ProE, AutoCAD, or similar)
- Ability to interpret and create engineering drawings and technical specifications
- Comfort with hand/power tools, precision measurement instruments, and electrical testing equipment
- Experience with root cause and problem-solving methodologies (DMAIC, 5 Whys, Fishbone, etc.)
- Working knowledge of ISO 9001 / 13485 quality systems
Nice to Have
- Medical device industry experience
- Knowledge of FDA regulations
- Six Sigma Green Belt or Black Belt certification
- Medical, dental, vision, short- and long-term disability, and life insurance starting the first of the month after your hire date
- 401(k) match and profit sharing
- Vacation time from day one
- 9 paid holidays for regular full-time employees
- Paid training
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