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. 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.

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

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

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

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 .