Xenter
Manufacturing Engineer / Production Supervisor
Draper, UT
Sponsorship not specifiedDetected 13 days ago
ComplianceSupply ChainProcess ImprovementERPRecruitingPerformance ManagementControlsGMPFDA RegulatoryMedical DevicesLeadershipCommunicationMentoringOrganizational SkillsMicrosoft OfficeGxP
About the role
- 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.
- 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.
Responsibilities
- 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.
- 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.
- Partner with Talent Acquisition and the People team to scale the first-
- shift team and build out a new second
- Coach, mentor, and develop assembly staff, including onboarding and training new hires and supporting operator certification/qualification requirements.
- Maintain a safe, organized, and disciplined production environment consistent with 5S and good manufacturing practice (GMP) principles.
Requirements
- Associate's or Bachelor's degree in Manufacturing Engineering, Mechanical/Industrial Engineering, or a related technical field
- 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.
- Proficiency with standard office and manufacturing systems (e.g., MRP/ERP, document control systems, MS Office/Google Workspace).
- Ability to stand and walk for extended periods
- Ability to lift up to 25 lbs occasionally (materials, fixtures, or equipment components).
Nice to have
- Experience supporting or leading process validation activities (IQ/OQ/PQ).
- Familiarity with statistical process control (SPC) and basic capability analysis (Cpk/Ppk).
- Six Sigma Green Belt or equivalent continuous improvement certification.
- Experience supporting FDA or Notified Body audits from the production floor.
Benefits
- Provide supervisory and technical coverage for second-
- SUPERVISORY RESPONSIBILITY This position directly supervises the medical device assembly team - currently 5-6 assemblers on first
- 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.
This listing is sourced directly from Xenter's careers page and normalized into a canonical job model.