Manufacturing Engineer / Production Supervisor
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.
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.
Essential Duties & Responsibilities
Making real-time diagnoses and resolutions of process, tooling, fixture, and equipment issues on the production floor to minimize downtime and rework.
Leading or supporting root cause analysis (e.g., 5 Why, fishbone) for process deviations, nonconformances, and equipment failures; implementing corrective and preventive actions.
Developing, revising, and maintaining work instructions, process routings, and fixture/tooling documentation in accordance with the Quality Management System.
Partnering with Quality and R&D/Engineering on process validations (IQ/OQ/PQ), engineering changes (ECOs), and new product introduction (NPI) transfers into production.
Evaluating and recommending capital equipment, tooling, and fixture investments to support scaling production volume.
Directly supervising 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.
Partnering 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.
Translating production plans, forecasts, and shifting priorities into clear daily and weekly work assignments for the assembly team.
Balancing workload across operators based on skill, capacity, and cross-training status to protect daily throughput and on-time delivery targets.
Cooking, mentoring, and developing assembly staff, including onboarding and training new hires and supporting operator certification/qualification requirements.
Conducting regular one-on-ones and performance conversations; contributing to hiring decisions and performance reviews for the assembly team.
Maintaining a safe, organized, and disciplined production environment consistent with 5S and good manufacturing practice (GMP) principles.
Providing 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.
Ensuring all assembly activities are performed in compliance with ISO 13485, 21 CFR 820, and applicable design history file (DHF) / device master record (DMR) requirements.
Ensuring accurate and timely completion of device history records (DHRs), batch records, and traceability documentation.
Serving as the primary point of contact between production staff and Engineering, Quality, and Operations leadership. Communicating schedule risks, resource constraints, and quality issues proactively to keep the production plan on track.
Participating in daily production/tier meetings and providing clear status updates on throughput, staffing, and open issues.
Collaborating 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.
Experience: 3+ years of manufacturing engineering or manufacturing/production support experience, ideally in medical device, life sciences, aerospace, or another highly regulated industry.
Supervisory Experience: 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
Mainly 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.