Senior Manufacturing Engineer - Assembly

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.

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

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.

Physical and Mental Demands

• 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

Work Environment

Primarily on the production floor supporting active assembly lines. Noise level is moderate to loud, and not all areas are climate controlled.