Production Manager

Production Manager

Medical Device Manufacturing | Concord, CA

Full-Time | Exempt

About the Rol

eThe Production Manager is responsible for leading all manufacturing operations within a regulated medical device manufacturing environment specializing in silicone processing. This role oversees molding, extrusion, calendering, assembly, gel lab, facilities, and machine shop operations to ensure production targets, quality standards, and regulatory compliance are consistently achieved

.
Direct medical device manufacturing experience is required. Candidates without regulated industry experience (FDA, ISO 13485) will not be considere

d.
Reporting to executive leadership, the Production Manager drives operational performance, regulatory compliance, team leadership, and continuous improvement initiativ

es.
Key Responsibili

tiesManufacturing Leader

• shipDirect and coordinate production operations across silicone molding, extrusion, calendering, assembly, and related departme
• nts.Lead four Supervisors and their respective production te
• ams.Review production schedules, product specifications, and delivery timelines to establish priorities and sequenc
• ing.Develop and plan work orders to support efficient manufacturing f
• low.Monitor equipment utilization and coordinate preventative maintenance activit
• ies.Analyze downtime, scrap, and throughput metrics to improve operational efficie

ncy.
Regulatory & Quality Compliance (Medical Device Requ

• ired)Ensure full compliance with FDA 21 CFR Part 820, cGMP, and ISO 1
• 3485.Apply formal risk management techniques such as FMEA, Hazard Analysis, and Fault Tree Anal
• ysis.Support internal and external audits and maintain inspection readi
• ness.Partner with Quality to ensure product specifications and documentation standards are mainta

ined.
Continuous Impro

• vementReview production and operating reports to identify improvement opportun
• ities.Implement process improvements focused on quality, cost control, and cycle time redu
• ction.Standardize operational procedures and enforce compliance across depart
• ments.Compile and present production data and KPI reporting to leade

rship.
Team Leadership & Deve

• lopmentInterview, hire, train, evaluate, and develop production per
• sonnel.Address employee concerns and foster a high-accountability, team-oriented c
• ulture.Promote safety, compliance, and operational discipline across depar
• tments.Collaborate cross-functionally with Materials Management, Logistics, Customer Service, Engineering, and Quality

teams.
Qualif

• icationsBachelor’s degree required; advanced degree pr
• eferred.10 years of manufacturing leadership exp
• erience.Medical Device manufacturing experience r
• equired.Strong working knowledge of FDA QSR, ISO 13485, a
• nd cGMP.Experience leading multi-department productio
• n teams.Background in silicone processing (molding, extrusion, calendering) highly pr
• eferred.Strong knowledge of MRP systems and production trackin
• g tools.Proven ability to drive performance improvements and reduce d
• owntime.Strong communication, analytical, and leadership

skills.
Com

• pensationBase Salary: $135,000 –
• $150,000Bonus Potential: 10%
• annuallyFull benefits package including health, dental, vision, 401(k), PTO,