POSITION PURPOSE & SUMMARY

Experienced operations leader responsible for safe, compliant, timely production of precision machine components. Accountable for meeting quality, regulatory, cost, delivery, and safety targets while driving continuous improvement, robust training programs, quality controls, customer relations, and people development.

ESSENTIAL FUNCTIONS

• Managing and leading medical device manufacturing operations.
• Lead day‑to‑day plant operations across production, packaging, sterilization (if applicable), maintenance, and facilities.
• Maintain and improve product quality, yield, and on‑time delivery metrics. Investigate and resolve nonconformances, CAPAs, NCRs, and recalls when needed.
• Design, implement, and sustain comprehensive training programs for production, quality, maintenance, and supervisory staff (onboarding, GMP, QMS, safety, SOPs, competency assessments). Track training effectiveness and ensure competency records are maintained.
• Establish, monitor, and enforce quality controls across manufacturing processes, including in‑process inspections, lot release criteria, SPC, first‑article inspections, and final product verification. Ensure effective sampling plans, test methods, and documentation.
• Oversee production planning, capacity management, and scheduling to meet customer demand and inventory targets.
• Manage customer relations: respond to RFQs, prepare and review new PO quotes (costing, lead‑times, capacity impact), negotiate delivery schedules and terms with sales/account managers, and host or conduct customer site visits and plant tours to support sales, qualification, and audits. Coordinate technical responses and ensure commitments are feasible and validated.
• Implement and sustain lean manufacturing, continuous improvement, and cost‑reduction initiatives (e.g., 5S, Kaizen, Six Sigma).
• Manage plant budget, P&L drivers, cost control, and capital projects.
• Ensure workplace health & safety, environmental compliance, and emergency preparedness.
• Collaborate with R&D, Quality, Regulatory Affairs, Supply Chain, and Sales on new product introductions, transfers, validations, change controls, and contract requirements.
• Oversee equipment validation, preventive maintenance, calibration programs, and supplier/contractor performance.
• Maintain accurate documentation, manufacturing records, training records, and metrics reporting to senior leadership.
• Drive continuous improvement of the QMS and training systems; participate in internal and external audits and implement corrective actions.

PROFESSIONAL REQUIREMENTS – KNOWLEDGE, SKILLS & ABILITIES:

Skills Required

• Hands‑on experience with CNC lathe and milling machines (turning, milling centers).
• CNC programming skills (G‑code, conversational, and CAM software such as Mastercam, Fusion 360, or Autodesk).
• Tooling selection and setup: toolholders, inserts, collets, endmills, drills, live tooling, and fixture design/placement.
• Machine setup and changeover: offsets, work holding, speeds/feeds optimization, probe setup, and first‑piece approval.
• Precision dimensional inspection: use of CMM, calipers, micrometers, height gauges, bore gauges, optical comparators, and surface finish measurement.
• Blueprint reading and tolerance interpretation, GD&T competency.
• SPC and in‑process inspection techniques; root‑cause analysis for dimensional nonconformances.
• Preventive maintenance and basic troubleshooting of CNC equipment.
• Strong attention to detail, quality focus, and ability to train/mentor operators on machining and inspection best practices.
• Preferred: certification or demonstrated experience in CNC machining, metrology, or precision manufacturing.

Required Qualifications

• Bachelor's degree in engineering, Manufacturing, Biomedical Engineering, Life Sciences, or related field.

Or

• 8+ years manufacturing experience with at least 3–5 years in a plant leadership role; medical device experience strongly preferred.
• Demonstrated success in operational excellence, process validation, and continuous improvement programs.
• Proven ability to design and manage training programs and maintain training records/competency matrixes.
• Experience interacting with customers for quoting, contract review, site visits, and technical negotiations.
• Proven ability to manage budgets, forecasting, and capital projects.
• Excellent leadership, communication, customer‑facing, problem‑solving, and cross‑functional collaboration skills.

License, Registration, and/or Certification Required

þ Valid Driver's License

PHYSICAL REQUIREMENTS, WORKING CONDITIONS & ENVIRONMENTAL FACTORS

• Plant environment with PPE requirements; ability to walk production floors and inspect equipment.
• May require overtime, shift coverage, and occasional travel to suppliers, customers, or other sites.

COMPENSATION & BENEFITS

• Competitive salary commensurate with experience plus performance bonus. Comprehensive benefits package (health, retirement, PTO, etc.).

Equal Opportunity

GMI is an equal opportunity employer and values diversity. Reasonable accommodation is available for qualified applicants.