Job 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. This job class has four experience levels: Process Engineer I, Process Engineer II, Senior Manufacturing Process Engineer, and Principal Manufacturing Process Engineer.
Essential Duties and Responsibilities- Review customer prints, BOMs, and specifications for assembly feasibility and build sequence; identify sub-assembly breakdown and flag Design for Assembly (DFA) issues to customers and Sales
- Provide build time, tooling, and fixture cost estimates to support quoting activities
- Define assembly sequence and station/line layout from sub-assembly stations through final assembly
- Design or source fixtures, jigs, and torque/fastening tools; set and validate torque specs, adhesive/sealant parameters, and press-fit forces
- Define kitting requirements per station and procure prototype/first article hardware and sub-assembly components
- Plan and run first article sub-assembly and final assembly builds; verify integration, fit, function, and torque retention
- Lead root cause analysis and containment on issues found during pilot builds
- Complete first article inspection (FAI) reports and customer approval packages; validate repeatability of critical joins
- Author work instructions per station, including torque/fastener callouts; complete PFMEAs and control plans for each sub-assembly and integration step
- Define operator training/certification requirements per station
- Assemble the process handoff package and lead the formal handoff review with Manufacturing Engineering; remain available as an escalation point during the post-handoff support window
- Follow and comply with all safety and work rules and regulations
- Independently own moderate-to-high complexity design transfers end-to-end, from DFA review and quoting support through first article, validation, and handoff
- Lead process development, sequencing, and fixture/tooling design for multi-station sub-assembly and final assembly builds
- Lead process capability studies (e.g., Cpk) on critical joins; support IQ/OQ activities where required
- Author and review PFMEAs, control plans, and validation protocols
- Lead root cause investigation and containment on pilot and early-production issues, coordinating with Quality and Manufacturing Engineering
- Represent Process Engineering in customer design reviews and first article approvals
- Identify and lead moderate-scope continuous improvement and cost-reduction initiatives within assigned programs
- Contribute to departmental templates and best practices for work instructions, PFMEA methodology, and validation protocols
- Mentor Process Engineer I team members
- 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
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position. The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.
- 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
Note: Years of Experience is a guideline. Promotion depends primarily on demonstrated performance, knowledge, and capability.
- 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
- Frequent standing, walking, and sitting in office and production environments
- Occasional bending, reaching, and light lifting (up to 40 lbs., if applicable)
- Visual acuity to review drawings and data and observe assembly processes, with color perception required
- High level of analytical thinking and problem-solving to evaluate build processes and identify root causes
- Ability to manage multiple programs simultaneously with shifting priorities
- High attention to detail with strong organizational skills
- Effective communication skills, including presenting to customers, production teams, and less experienced engineers
- Ability to receive and provide instructions in a positive manner
Work Environment
- Office environment with frequent need to be on the production floor supporting builds and pilot runs
- In the production facility, noise level is moderate to loud, and not all areas are climate controlled
Skills Required
- 7 to 15 years of manufacturing or process engineering experience in mechanical or electromechanical assembly
- At least 3 years launching new assembly processes
- Experience leading new process introductions from quoting through first article, validation, and production release
- Experience designing or specifying assembly fixtures and tooling
- Experience setting torque, fastening, adhesive, sealant, and press-fit production parameters
- Experience authoring and maintaining PFMEAs, control plans, work instructions, engineering change controls, and process requalification documentation
- Experience leading root-cause and corrective-action investigations using 8D, 5 Why, or fishbone methods
- Experience completing IQ/OQ/PQ process validation and FAI in an ISO 13485, ISO 9001, or similarly regulated environment
- Experience mentoring engineers and training or certifying production operators
- Proficiency in SolidWorks or equivalent CAD software
- Lean or Six Sigma certification at Green Belt level or higher
- Medical device assembly experience
- Bachelor’s degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering, or a related technical field; may be waived with sufficient experience
What We Do
MPE Inc. has developed the only capital equipment commercialization platform that enables healthcare and technology OEMS to scale, integrate, and extend their medical device commercial strategies. Our purpose-built platform integrates the most critical control planes of compliance, differentiation, and adoption readiness into one unified system. This approach provides MedTech OEMs with a clear roadmap to market-ready products, meeting the modern healthcare demand for high-quality, life-transforming devices as soon as possible- addressing the common challenges associated with outdated, siloed contract manufacturing operations. Headquartered in Milwaukee, WI, MPE Inc. utilizes our legacy of over 40 years of expertise and experience to successfully service an impressive list of blue-chip medical devices and technology OEMs. Our commitment to guiding customers to the right solution the first time is highlighted by our experience and capabilities. We leverage our knowledge and expertise to ensure that our customers get the most suitable solution for their requirements. We are proud to be an ISO 13485 & 9001 certified company. FDA registration 3003500271.
