Manufacturing Engineer​/Production Supervisor

Manufacturing Engineer & Production Supervisor

The Manufacturing Engineer & Production Supervisor is a hands-on, working leadership role responsible for both the technical performance of the medical device assembly line and the day-to-day supervision of the assembly team. This person owns the troubleshooting and continuous improvement of manufacturing tools, fixtures, and processes to ensure consistent production output that meets quality and schedule targets, while directly supervising, coaching, and developing the assembly team through a period of active growth.

The team currently consists of 5–6 assemblers on first shift; this role is expected to help scale that team and potentially build a new second shift, with each shift projected to grow to approximately 8–12 assemblers in the short term.

This role translates overall production plans and priorities into clear individual work assignments, balances workload across the team, and maintains accountability for daily throughput and on-time delivery. The position is anchored to a standard, first-shift schedule but is expected to extend oversight to a second production shift as volume and staffing require, ensuring consistent technical and supervisory coverage across both shifts.

The ideal candidate is self-motivated, technically capable of diagnosing and resolving process or equipment issues directly on the floor, and comfortable operating in a regulated medical device manufacturing environment. This person also serves as the primary point of contact between production staff and engineering, quality, and operations leadership to keep the production schedule on track.

Manufacturing Engineering & Continuous Improvement

• Diagnose and resolve process, tooling, fixture, and equipment issues on the production floor in real time to minimize downtime and rework.

• Own the ongoing improvement of manufacturing tools, fixtures, and assembly processes, driving measurable gains in yield, cycle time, and first-pass quality.

• Lead or support root cause analysis (e.g., 5 Why, fishbone) for process deviations, nonconformances, and equipment failures; implement corrective and preventive actions.

• Develop, revise, and maintain work instructions, process routings, and fixture/tooling documentation in accordance with the Quality Management System.

• Partner with Quality and R&D/Engineering on process validations (IQ/OQ/PQ), engineering changes (ECOs), and new product introduction (NPI) transfers into production.

• Evaluate and recommend capital equipment, tooling, and fixture investments to support scaling production volume.

Production Supervision & Team Leadership

• Directly supervise the assembly team — currently 5–6 assemblers on first shift, growing toward 8–12 assemblers per shift — including scheduling, attendance, performance management, and disciplinary action as needed.

• Partner with Talent Acquisition and the People team to scale the first-shift team and build out a new second shift from the ground up, including interviewing, onboarding, and ramping new assemblers to full productivity.

• Translate production plans, forecasts, and shifting priorities into clear daily and weekly work assignments for the assembly team.

• Balance workload across operators based on skill, capacity, and cross-training status to protect daily throughput and on-time delivery targets.

• Coach, mentor, and develop assembly staff, including onboarding and training new hires and supporting operator certification/qualification requirements.

• Conduct regular one-on-ones and performance conversations; contribute to hiring decisions and performance reviews for the assembly team.

• Maintain a safe, organized, and disciplined production environment consistent with 5S and good manufacturing practice (GMP) principles.

• Provide supervisory and technical coverage for second-shift production as needed, adjusting personal schedule to ensure the second shift has consistent access to leadership, troubleshooting support, and clear priorities.

Quality & Regulatory Compliance

• Ensure all assembly activities are performed in compliance with ISO 13485, 21 CFR 820, and…