Production Manager

Medical Device Manufacturing Woodland CA
Full-Time Exempt

The 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 considered.

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

• Direct and coordinate production operations across silicone molding extrusion calendering assembly and related departments.
• Lead four Supervisors and their respective production teams.
• Review production schedules product specifications and delivery timelines to establish priorities and sequencing.
• Develop and plan work orders to support efficient manufacturing flow.
• Monitor equipment utilization and coordinate preventative maintenance activities.
• Analyze downtime scrap and throughput metrics to improve operational efficiency.

• Ensure full compliance with FDA 21 CFR Part 820 cGMP and ISO 13485.
• Apply formal risk management techniques such as FMEA Hazard Analysis and Fault Tree Analysis.
• Support internal and external audits and maintain inspection readiness.
• Partner with Quality to ensure product specifications and documentation standards are maintained.

• Review production and operating reports to identify improvement opportunities.
• Implement process improvements focused on quality cost control and cycle time reduction.
• Standardize operational procedures and enforce compliance across departments.
• Compile and present production data and KPI reporting to leadership.

• Interview hire train evaluate and develop production personnel.
• Address employee concerns and foster a high-accountability team-oriented culture.
• Promote safety compliance and operational discipline across departments.
• Collaborate cross-functionally with Materials Management Logistics Customer Service Engineering and Quality teams.

• Bachelors degree required; advanced degree preferred.
• 10 years of manufacturing leadership experience.
• Medical Device manufacturing experience required.
• Strong working knowledge of FDA QSR ISO 13485 and cGMP.
• Experience leading multi-department production teams.
• Background in silicone processing (molding extrusion calendering) highly preferred.
• Strong knowledge of MRP systems and production tracking tools.
• Proven ability to drive performance improvements and reduce downtime.
• Strong communication analytical and leadership skills.