Senior Process Engineer - Assembly
MPE-Inc
Summary
Process Engineering is responsible for developing new assembly and sub-assembly manufacturing processes for electromechanical products, from manufacturability review and quoting support through first article build, process validation, and release to Manufacturing Engineering. Process Engineering partners with Manufacturing Engineering, Quality, and customers to ensure new processes are producible, repeatable, and fully documented before transfer to production.
Job description
Essential Duties and Responsibilities
- Serve as technical lead for assembly process development on assigned programs; apply and help develop engineering standards for fixtures, torque/fastening control, work instructions, PFMEAs, and control plans
- Own and continuously improve the NPD-to-Production handoff process, including handoff package requirements, joint walkthroughs, and the post-handoff support window
- Lead manufacturability reviews and drive DFA feedback to customers and Sales; develop and review build time, tooling, fixture, and capital cost estimates
- Lead process validation (IQ/OQ/PQ or equivalent) for new and changed processes
- Author and approve work instructions, DHR documents, PFMEAs, and process validations
- Present process plans, validation results, and corrective actions to customers and internal leadership
- Support customer and regulatory audits as the process subject-matter expert
- Prioritize and coordinate engineering workload across multiple programs with the Process Engineering Manager
- Review designs, documentation, and validation work completed by Process Engineer I and II team members
- Mentor Process Engineer I and II and Manufacturing Engineer team members
Experience and Knowledge
- 7 to 15 years of manufacturing or process engineering experience in mechanical/electromechanical assembly, including at least 3 years launching new assembly processes
- Led new process introductions from quote through first article, validation, and release to production
- Designed or specified assembly fixtures and tooling, and set torque/fastening, adhesive/sealant, and press-fit parameters for production
- Authored and maintained PFMEAs, control plans, and work instructions, including engineering change control and re-qualification on released processes
- Led root cause and corrective action investigations (8D, 5 Why, fishbone) that delivered measurable gains in yield, scrap, or cycle time
- Completed process validation (IQ/OQ/PQ) and FAI in an ISO 13485, ISO 9001, or similarly regulated environment
- Mentored engineers and trained or certified production operators
- Proficient in SolidWorks or equivalent CAD
- Lean or Six Sigma certification (Green Belt or higher) and medical device assembly experience preferred
Education
Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, or a related technical field. Degree requirement may be waived with sufficient engineering-related work experience.
Requirements
- 7 to 15 years of manufacturing or process engineering experience in mechanical/electromechanical assembly
- At least 3 years launching new assembly processes
- Led new process introductions from quote through first article, validation, and release to production
- Designed or specified assembly fixtures and tooling, and set torque/fastening, adhesive/sealant, and press-fit parameters for production
- Authored and maintained PFMEAs, control plans, and work instructions, including engineering change control and re-qualification on released processes
- Led root cause and corrective action investigations (8D, 5 Why, fishbone) that delivered measurable gains in yield, scrap, or cycle time
- Completed process validation (IQ/OQ/PQ) and FAI in an ISO 13485, ISO 9001, or similarly regulated environment
- Mentored engineers and trained or certified production operators
- Proficient in SolidWorks or equivalent CAD
- Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, or a related technical field
- Lean or Six Sigma certification (Green Belt or higher) preferred
- Medical device assembly experience preferred
Company overview
MPE-Inc, also known as Midwest Products & Engineering, is a leading medical device manufacturer specializing in custom medical equipment carts and capital equipment commercialization platforms. Founded in 1978 and headquartered in Milwaukee, Wisconsin, the company has established itself as the largest custom medical cart manufacturer in the United States. With over 40 years of industry expertise, MPE-Inc serves blue-chip medical device and technology OEMs through its vertically integrated business model that offers comprehensive "Concept to Completion" solutions. The company's innovative MACH Series provides modular, customizable cart components that accommodate over 95% of medical devices, enabling healthcare OEMs to achieve faster time-to-market, lower costs, and reduced development risks. MPE-Inc's FDA-registered facility maintains ISO 13485 and 9001 certifications, ensuring compliance with rigorous medical device manufacturing standards. The company's unique commercialization platform integrates design, development, manufacturing, and lifecycle support services, addressing critical healthcare needs including ventilator carts during the COVID-19 pandemic. With a workforce of 51-200 employees, MPE-Inc continues to pioneer medical equipment mobility solutions that enhance clinical workflows and patient care delivery across diverse healthcare settings.