Molding Operations Leader — Lean Manufacturing & Growth

SMC Ltd.; Santa Rosa (CA); On-site; USD 140,000 - 165,000; Full time

Job summary

SMC Ltd. in Santa Rosa, CA seeks a Manager, Manufacturing Operations - Molding to lead multi‑shift molding operations, drive productivity, and ensure quality, safety, and cost control.

You will guide engineering alignment with customer requirements and define clear direction and goals across the department. The role requires an engineering degree and 10+ years of management experience in medical device manufacturing, with expertise in Lean, GMPs, and ISO13485.

Qualifications

• Engineering degree and ten (10) years of management experience required.
• Strong knowledge of Medical Device manufacturing, ISO13485, FDA regulations, and GMPs.
• Champion for productivity improvements and lean manufacturing techniques.
• Strong project management skills with a high sense of urgency.
• Able to coordinate workflow across shifts and manage a team.

Responsibilities

• Lead molding operations across multiple shifts to meet production schedules.
• Provide technical training and guidance for all areas of Molding and subassembly manufacturing.
• Lead, inspire and execute Lean manufacturing principles and process improvements.
• Develop and coach supervisors and direct reports; reinforce desired behavior.
• Study schedules; optimize tooling, fixtures and automation to meet delivery dates.
• Maintain standard work for self and team; adhere to BoM, 6S and GMPs.
• Budget for manufacturing including approvals of spending and cost control.
• Communicate quality issues, CAPAs, and important decisions to staff.

Skills

Leadership

Lean Six Sigma

Automation

Project management

Communication

GMPs

ISO13485 / FDA

IQMS / ERP

Education

Engineering degree

Tools

IQMS ERP

Job description

SMC Ltd. in Santa Rosa, CA seeks a Manager, Manufacturing Operations - Molding to lead multi‑shift molding operations, drive productivity, and ensure quality, safety, and cost control.

You will guide engineering alignment with customer requirements and define clear direction and goals across the department. The role requires an engineering degree and 10+ years of management experience in medical device manufacturing, with expertise in Lean, GMPs, and ISO13485.