Job Summary
Manufacturing Engineering - Assembly is responsible for sustaining and continuously improving released assembly and sub-assembly manufacturing processes for electromechanical products. This includes day-to-day process performance, change control, and operator training at each station, as well as receiving and supporting new processes from Process Engineering through a formal handoff. This job class has four experience levels: Manufacturing Engineer I, Manufacturing Engineer II, Senior Manufacturing Process Engineer, and Principal Manufacturing Process Engineer.
Essential Duties and Responsibilities- Monitor station-level performance (yield, scrap, rework, and cycle time) by sub-assembly and final assembly station
- Triage and resolve day-to-day fit, fastening, and fixture issues on the floor; support operators with troubleshooting escalations
- Maintain fixtures, torque tools, and gauges already in production
- Drive root cause / corrective action on recurring fit, fastening, or rework issues
- Lead improvement projects such as line balancing, station cycle time reduction, kitting efficiency, and fixture upgrades
- Update work instructions, control plans, and PFMEAs as the build process evolves
- Own engineering change requests on released assembly/sub-assembly processes; assess the impact of part, hardware, or sequence changes on downstream stations
- Update documentation and retrain operators as needed; coordinate re-qualification when changes affect form, fit, or function
- Train and certify operators per station; maintain visual aids and work instructions at each workstation
- Participate in daily production/tier meetings
- Participate in the joint handoff walkthrough with Process Engineering to confirm clean process handoff from NPD to Production
- Follow and comply with all safety and work rules and regulations
- Own sustaining performance (yield, scrap, rework, and cycle time) for an assigned set of assembly/sub-assembly stations or a full production line
- Independently troubleshoot and resolve moderate-to-complex fit, fastening, and fixture issues; escalate only high-risk or novel issues
- Lead root cause / CAPA investigations for recurring or higher-severity issues spanning multiple stations
- Lead continuous improvement projects with measurable results
- Own engineering change requests of moderate complexity; assess multi-station impact and coordinate re-qualification of affected joins
- Maintain and improve control plans and PFMEAs for assigned stations as processes evolve
- Serve as the primary Manufacturing Engineering point of contact during handoff reviews for assigned product lines
- Support internal and customer audits as a station/line-level subject matter expert
- Mentor Manufacturing Engineer I team members and oversee operator training and certification for assigned lines
- Serve as technical lead for sustaining activities on assigned production lines; apply and help develop engineering standards for fixtures, torque/fastening control, work instructions, PFMEAs, and control plan
- Set yield, scrap, rework, and cycle time improvement targets and lead projects to meet them, including automation and error-proofing opportunities
- Lead root cause / corrective action (CAPA) on complex or recurring issues from pilot builds through production
- Own and continuously improve the NPD-to-Production handoff process, including handoff package requirements, joint walkthroughs, and the post-handoff support window
- 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 corrective actions and improvement results to customers and internal leadership
- Support customer and regulatory audits as the process subject-matter expert
- Prioritize and coordinate engineering workload across production lines with the Process Engineering Manager
- Review work and documentation completed by Manufacturing Engineer I and II team members
- Mentor Manufacturing Engineer I and II and Process 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.
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
- Frequent standing and walking on the production floor
- Occasional bending, reaching, and light lifting (up to 40 lbs., if applicable)
- Visual acuity to observe assembly operations and inspect work, with color perception required
- Strong troubleshooting and problem-solving skills under production time pressure
- Ability to manage multiple stations, projects, and priorities simultaneously
- High attention to detail with strong organizational skills
- Effective communication with operators, quality, process engineering, and less experienced engineers
- Ability to receive and provide instructions in a positive manner
The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.
Work Environment
- Primarily on the production floor supporting active assembly lines
- Noise level is moderate to loud, and not all areas are climate controlled
The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.
Skills Required
- 7 to 15 years of manufacturing or process engineering experience in mechanical or electromechanical assembly
- At least 3 years of experience launching new assembly processes
- Experience leading new process introductions from quote 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 control, 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 First Article Inspection 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
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.
.png)
