Manufacturing Engineer​/Production Supervisor

Manufacturing Engineer / Production Supervisor

About Xenter is advancing a new generation of medical technologies—from diagnostic tools that help identify conditions earlier to procedural innovations designed to support more cost-effective treatment options across a broad patient population. By improving how conditions are identified and how procedures are performed, Xenter provides clinicians with real-time insight to support more precise and consistent decision‑making. These products are designed with a strong focus on data, validation, and continuous improvement.

Building on this foundation, Xenter is developing a connected clinical intelligence platform that captures and organizes data across procedures and care settings. This platform enables health systems to expand access to advanced diagnostic tools while helping address barriers to care. Over time, this approach is designed to support more efficient care delivery and lower the total cost of care—creating value for providers, health systems, and patients.

At Xenter, you'll join an entrepreneurial team where innovation moves quickly, ideas become reality, and every employee has the opportunity to help shape technologies with the potential to change healthcare worldwide. You'll work alongside industry leaders, influence the direction of a rapidly growing company, and help bring breakthrough technologies from concept to commercialization.

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.

• 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.
• Directly supervise the assembly team — currently 5–6 assemblers on first shift, growing toward 8–12 assemblers per shift — including scheduling, attendance,…