Molding Operations Manager — Lean Medical Devices

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

Job summary

SMC Ltd. in Santa Rosa, CA is seeking a Manager of Manufacturing Operations - Molding to lead multi-shift molding, drive productivity, and ensure quality, safety, and cost control. You will align engineering efforts with customer requirements and establish clear strategy and goals for the department.

The role requires an engineering degree and 10 years of management experience, plus strong leadership, Lean, and GMP knowledge to improve processes and meet delivery commitments.

Qualifications

• Engineering degree and ten years of management experience required.
• Strong leadership and change management skills.
• Excellent communication, analytical/problem solving, negotiation and planning abilities.
• Extensive knowledge of Medical Device manufacturing, ISO13485 and FDA regulations, and GMPs.

Responsibilities

• Provide leadership for molding operations across multiple shifts and meet production schedules.
• Lead Lean manufacturing and process-improvement initiatives.
• Develop and coach supervisors; ensure training and development of department staff.
• Drive budgeting, cost control and adherence to BoM standards and safety.
• Coordinate tooling, fixtures, automation, and capacity planning to meet delivery dates.
• Ensure standard work and 6S within the department and cross-functionally.

Skills

Leadership

Communication

Project management

Lean manufacturing

Automation knowledge

GMPs compliance

Regulatory knowledge (ISO13485/FDA)

IQMS/ERP familiarity

Education

Engineering degree

Tools

Word

Excel

Access

IQMS

Job description

SMC Ltd. in Santa Rosa, CA is seeking a Manager of Manufacturing Operations - Molding to lead multi-shift molding, drive productivity, and ensure quality, safety, and cost control. You will align engineering efforts with customer requirements and establish clear strategy and goals for the department.

The role requires an engineering degree and 10 years of management experience, plus strong leadership, Lean, and GMP knowledge to improve processes and meet delivery commitments.