Director Of Operations

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 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.





Salary range: $170 - $230K