Job Summary:The Production Manager & Site Lead is the primary operational leader responsible for all activities at the Half Moon Bay, CA facility. This role ensures safe, compliant, and efficient production operations while acting as the on-site point of accountability for production, facilities, and site performance. The position partners closely with onsite engineering team to align production with new product introduction and customer project timelines. This role reports to the VP of Operations and is directly responsible for the team of production admin and direct labor staff on site.
Duties/Essential Job Functions:- Serve as primary point of responsibility for all site operations
- Own site KPIs including safety, quality, delivery, and cost
- Lead, coach, and develop production staff
- Manage production workflow and scheduling
- Partner with engineering to align production with NPI timelines
- Identify and resolve production bottlenecks
- Support NPD activities through prototype and V&V production activities
- Engage in transfer from NPD to Production both intra- and inter-site.
- Ensure readiness of work instructions, tooling, and training
- Ensure compliance with Cal/OSHA and environmental regulations
- Maintain adherence to FDA QSR and ISO 13485
- Drive CAPA and root cause activities
- Lead process improvement initiatives
- Oversee facility, equipment, and maintenance readiness
- Coordinate with Houston facility and travel as needed
Required Education/Experience:- Bachelor's degree in Engineering, Manufacturing, or related field.
- 7-10 years of manufacturing experience in regulated industry.
- 3-5 years leadership experience.
- Familiarity with MES and ERP systems. Misys, Syteline, and QuickBooks is advantageous.
- Knowledge of FDA QSR and ISO 13485.
- Familiarity with California safety and environmental regulations.
Physical Requirements:Ability to stand for extended periods, lift up to 25 lbs occasionally, and work in a manufacturing environment.
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