Director, Operations

About the role

Lead Supply Chain, Production, and Production Engineering for a regulated medical device company, driving safety, quality, delivery, cost and compliance across manufacturing scale‑up and new product introduction.

Key responsibilities

• Direct daily manufacturing operations to ensure safe, efficient, on‑schedule production in compliance with quality system procedures.
• Develop and execute plans to improve quality, throughput, capacity, inventory and cost performance.
• Provide engineering leadership for process development, equipment selection, automation, validation and continuous improvement.
• Partner with Design Engineering, Quality, Regulatory and Program Management for design transfer and scale‑up.
• Oversee production planning, material availability, inventory management and supplier performance.
• Establish and monitor KPIs for safety, quality, delivery, productivity, inventory and cost.

Required profile

• Bachelor's degree in Mechanical, Manufacturing, Electrical Engineering or related discipline.
• At least 10 years of progressive experience in medical device manufacturing or operations.
• Minimum 5 years of leadership experience managing manufacturing, supply chain or engineering teams.
• Proven track record with manufacturing engineering, production operations, supply chain management and quality systems.

Required skills

• Working knowledge of FDA Quality System Regulation and ISO 13485.
• Experience with ERP and Manufacturing Execution Systems.
• Implementation of automation, Lean Manufacturing, Six Sigma and continuous improvement methods.
• Strong analytical and data‑driven decision‑making abilities.

What we offer

• Comprehensive medical and dental coverage, FSA/HSA options with company contributions.
• 401(k) program with employer match.
• Generous vacation accrual and paid holidays.