Director of Operations

Cypress HCM; Irvine (CA); On-site; USD 180,000 - 320,000; Full time

Job summary

Cypress HCM in Irvine, CA seeks a seasoned Operations leader to direct direct supply chain, manufacturing engineering, and production operations within a regulated medical device environment. You will drive safety, quality, schedule adherence, and cost performance across multi-functional teams.

Responsibilities include developing operational plans, scale-up of new products, CAPA programs, budgeting, and KPI governance, with a focus on continuous improvement and compliance with FDA QSR, ISO

Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, or Electrical Engineering, or a related engineering discipline.
• At least 10 years of progressively responsible experience in medical device manufacturing or operations.
• At least five years of leadership experience managing manufacturing operations, supply chain, and/or engineering teams.
• Demonstrated experience in manufacturing engineering, production operations, supply chain management, and quality systems.
• Experience with process validation, equipment qualification, manufacturing scale-up, and design transfer.
• Experience managing budgets, capital projects, resource plans, and operational performance metrics.

Responsibilities

• Direct supply chain, production, and manufacturing engineering activities in accordance with established quality system procedures.
• Lead daily manufacturing operations to ensure products are produced safely, efficiently, on schedule, and in compliance with applicable requirements.
• Develop and execute operational plans to improve quality, throughput, capacity, inventory, and cost performance.
• Provide engineering leadership for manufacturing process development, equipment selection, automation, process validation, and continuous improvement.
• Partner with Design Engineering, Quality, Regulatory, and Program Management to support new product introductions, design transfers, and manufacturing scale-up.
• Oversee production planning, material availability, inventory management, supplier performance, and supply continuity.
• Establish and monitor KPIs related to safety, quality, delivery, productivity, inventory, and cost.
• Develop departmental budgets, staffing plans, capital expenditure justifications, and resource recommendations.
• Lead investigations and the implementation of corrective and preventive actions related to manufacturing and supplier issues.
• Ensure manufacturing processes remain validated and compliant with applicable medical device regulations, standards, and internal procedures.
• Develop organizational capabilities through hiring, coaching, performance management, and succession planning.
• Support internal, customer, and regulatory audits and ensure the timely completion of Operations-related corrective actions.
• Establish and maintain standard operating procedures, work instructions, and forms related to assigned areas of responsibility.
• Perform other duties as assigned.

Skills

Leadership

Budgeting

Manufacturing

Process Improvement

Quality Systems

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in Mechanical, Manufacturing, or Electrical Engineering

Tools

ERP systems

Manufacturing Execution Systems (MES)

Job description

• Direct supply chain, production, and manufacturing engineering activities in accordance with established quality system procedures.
• Lead daily manufacturing operations to ensure products are produced safely, efficiently, on schedule, and in compliance with applicable requirements.
• Develop and execute operational plans to improve quality, throughput, capacity, inventory, and cost performance.
• Provide engineering leadership for manufacturing process development, equipment selection, automation, process validation, and continuous improvement.
• Partner with Design Engineering, Quality, Regulatory, and Program Management to support new product introductions, design transfers, and manufacturing scale-up.
• Oversee production planning, material availability, inventory management, supplier performance, and supply continuity.
• Establish and monitor key performance indicators related to safety, quality, delivery, productivity, inventory, and cost.
• Develop departmental budgets, staffing plans, capital expenditure justifications, and resource recommendations.
• Lead investigations and the implementation of corrective and preventive actions related to manufacturing and supplier issues.
• Ensure manufacturing processes remain validated and compliant with applicable medical device regulations, standards, and internal procedures.
• Develop organizational capabilities through hiring, coaching, performance management, and succession planning.
• Support internal, customer, and regulatory audits and ensure the timely completion of Operations-related corrective actions.
• Establish and maintain standard operating procedures, work instructions, and forms related to assigned areas of responsibility.
• Perform other duties as assigned.

Required Education And Experience

• Bachelor’s degree in Mechanical, Manufacturing, or Electrical Engineering, or a related engineering discipline.
• At least 10 years of progressively responsible experience in medical device manufacturing or operations.
• At least five years of leadership experience managing manufacturing operations, supply chain, and/or engineering teams.
• Demonstrated experience in manufacturing engineering, production operations, supply chain management, and quality systems.
• Experience with process validation, equipment qualification, manufacturing scale-up, and design transfer.
• Experience managing budgets, capital projects, resource plans, and operational performance metrics.

Preferred Experience And Qualifications

• Experience leading operations within a Class II or Class III medical device environment.
• Working knowledge of FDA Quality System Regulation, ISO 13485, and applicable international medical device requirements.
• Experience working with enterprise resource planning and manufacturing execution systems.
• Experience implementing automation, Lean Manufacturing, Six Sigma, and structured continuous improvement methodologies.
• Strong analytical and problem-solving skills with the ability to make data-driven decisions.
• Excellent communication skills, including the ability to influence cross-functional teams and represent Operations to internal and external stakeholders.
• Proven ability to build, develop, and lead high-performing teams.
• Ability to manage multiple priorities in a fast-paced, highly regulated manufacturing environment.