Manufacturing Engineer / Production Supervisor in Draper, Utah at Xenter

About Xenter

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.

POSITION SUMMARY

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.

ESSENTIAL DUTIES & RESPONSIBILITIES

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 applicable design history file (DHF) / device master record (DMR) requirements.

• Ensure accurate and timely completion of device history records (DHRs), batch records, and traceability documentation.

• Support internal and external audits (e.g., FDA, Notified Body, customer) by providing floor-level process knowledge and documentation.

• Identify and escalate quality events, nonconformances, and CAPA needs promptly through established QMS channels.

Cross-Functional Communication

• Serve as the primary point of contact between production staff and Engineering, Quality, and Operations leadership.

• Communicate schedule risks, resource constraints, and quality issues proactively to keep the production plan on track.

• Participate in daily production/tier meetings and provide clear status updates on throughput, staffing, and open issues.

• Collaborate with Supply Chain and Materials on component availability, line-side inventory, and shortage mitigation as it affects the schedule.

SUPERVISORY RESPONSIBILITY

This position directly supervises the medical device assembly team — currently 5–6 assemblers on first shift, with a plan to scale each of two shifts (first and newly-established second) to approximately 8–12 assemblers. Supervisory duties include work assignment and scheduling, training and development, performance management, coaching, and active participation in hiring as the team scales, in coordination with the People team.

REQUIRED QUALIFICATIONS

Education & Experience

• Associate's or Bachelor's degree in Manufacturing Engineering, Mechanical/Industrial Engineering, or a related technical field; equivalent hands-on manufacturing experience may substitute for formal education.

• 3+ years of manufacturing engineering or manufacturing/production support experience, ideally in medical device, life sciences, aerospace, or another highly regulated industry.

• 1+ years of direct supervisory or lead experience with a production or assembly team.

Knowledge, Skills & Abilities

• Working knowledge of ISO 13485 and 21 CFR 820 quality system requirements as they apply to production and process control.

• Demonstrated ability to troubleshoot mechanical, electromechanical, or fixture-based assembly processes without waiting on escalation.

• Experience with process improvement methods (Lean, 5S, Kaizen, DMAIC, or similar) applied on a real production floor, not only in theory.

• Comfort reading and working from engineering drawings, work instructions, and bills of materials.

• Strong prioritization and organizational skills; able to re-sequence work assignments in response to shifting priorities without losing team accountability.

• Clear, direct communication style; able to translate between floor-level operational detail and engineering/quality/leadership audiences.

• Proficiency with standard office and manufacturing systems (e.g., MRP/ERP, document control systems, MS Office/Google Workspace).

PREFERRED QUALIFICATIONS

• Experience supporting or leading process validation activities (IQ/OQ/PQ).

• Familiarity with statistical process control (SPC) and basic capability analysis (Cpk/Ppk).

• Experience with electromechanical, catheter-based, or single-use disposable medical device assembly.

• Six Sigma Green Belt or equivalent continuous improvement certification.

• Experience supporting FDA or Notified Body audits from the production floor.

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Primarily performed on a manufacturing production floor in a cleanroom or controlled-environment setting; may require gowning, hairnets, or other PPE.

• Ability to stand and walk for extended periods; frequent bending, reaching, and use of hands for fine assembly and fixture manipulation.

• Ability to lift up to 25 lbs occasionally (materials, fixtures, or equipment components).

• Close visual work using microscopes, magnification, or fine tooling for extended periods.

• Exposure to standard manufacturing environment conditions; adherence to all site EHS and quality system requirements is required.

• Schedule is first shift to start; flexibility needed to adjust hours or presence to support a potential second-shift production is required as business needs dictate.

This job description reflects the general nature and level of work performed and is not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Xenter reserves the right to modify this description at any time to reflect evolving business needs.