Director, Operations
$170,000–$230,000 year
On-siteIrvine, California, United States
Job Summary
Direct supply chain, production, and production engineering activities to achieve safety, quality, delivery, cost, and compliance objectives in a regulated medical device environment. Lead daily manufacturing operations to ensure products are produced safely, efficiently, on schedule, and in compliance with applicable requirements. Develop operational plans to improve quality, throughput, capacity, inventory, and cost performance while partnering with cross-functional teams for new product introduction and manufacturing scale-up. Oversee production planning, material availability, inventory management, and supplier performance. Establish and monitor key performance indicators for safety, quality, delivery, productivity, inventory, and cost. Lead investigations of manufacturing and supplier issues, ensure processes remain validated, and develop organizational capability through hiring and succession planning. This role supports the development of the world's first bionic pancreas, the iLet, and requires up to 20% international travel.
Required Qualifications
- Bachelor's degree in Mechanical, Manufacturing, Electrical Engineering, or a related engineering discipline
- Minimum of ten (10) years of progressively responsible experience in medical device manufacturing or operations
- Minimum of five (5) years of leadership experience managing manufacturing operations, supply chain, and/or engineering teams
- Demonstrated experience with 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
Desired Qualifications
- Experience leading operations in 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 with ERP and Manufacturing Execution Systems
- Experience implementing automation, Lean Manufacturing, Six Sigma, and structured continuous improvement methods
- 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 audiences
- Proven ability to build, develop, and lead high-performing teams
- Ability to manage multiple priorities in a fast-paced, highly regulated manufacturing environment
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