Genesee BioMedical, Inc. Production Manager – Medical Devices Denver, CO · Full time Company website

Apply for Production Manager – Medical Devices

A global leader, partner and resource for innovative medical devices and instrumentation. We design develop and manufacture unsurpassed quality products in the cardiac surgical space.

About the Role

Genesee BioMedical, Inc. is looking for an experienced Production Manager to lead manufacturing operations at our Denver, CO facility. You’ll own daily production performance, regulatory compliance, and the growth of a team of supervisors, leads, and operators across our cleanroom, packaging, and metal manufacturing areas. This is a hands-on leadership role for someone who thrives on building strong teams, hitting targets, and making processes better every day.

What You’ll Do

• Direct daily production across all shifts and product lines to meet schedule, output, cost, and quality targets.
• Own the production plan, capacity, and staffing model in line with the master schedule and customer demand.
• Own on-time delivery and ERP/MES data integrity; report performance to senior leadership and represent production in S&OP and customer meetings.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, GMP, and company SOPs, including cleanroom gowning and environmental protocols.
• Keep batch records, device history records (DHRs), and production logs accurate and audit-ready; lead production’s role in internal, customer, and regulatory audits.
• Partner with Quality, Engineering, Maintenance, and Supply Chain on root cause investigations and CAPAs.
• Own production KPIs (OEE, yield, scrap, labor efficiency, schedule attainment) and lead Lean, Six Sigma, 5S, and kaizen initiatives.
• Manage the department budget, labor costs, and capital equipment and process improvement projects.
• Lead, coach, and develop Production Supervisors and Leads; own hiring, onboarding, training, performance reviews, and succession planning.
• Build a culture of safety, quality, and continuous improvement.

What You Bring

• 7+ years of progressive manufacturing leadership experience in a regulated environment, including 3–5 years in a supervisory or management role; medical device experience preferred.
• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP.
• Experience managing department budgets, labor costs, and capital or cross-functional improvement projects.
• Excellent leadership, planning, and communication skills, with the ability to influence across functions.
• Proficiency with Microsoft Office and ERP/MES systems.
• Bachelor’s degree in Engineering, Operations Management, Life Sciences, or a related field preferred; equivalent combination of education and experience considered.

Nice to Have

• Cleanroom or sterile manufacturing experience (ISO Class 7 or 8).
• Lean or Six Sigma certification.