Director, Operations (Medical Devices)

Location: Based out of the office in Irvine, California; many duties may be performed remotely. Up to 20% travel is required, including some international travel.

Salary: $170,000–$230,000 per year

Company

hirify.global is a medical technology company developing the iLet Bionic Pancreas, an insulin delivery system for type 1 diabetes management.

What you will do

• Lead Supply Chain, Production, and Production Engineering activities across safety, quality, delivery, cost, and compliance objectives.
• Direct daily manufacturing operations and improve throughput, capacity, inventory, quality, and cost performance.
• Provide engineering leadership for process development, equipment selection, automation, process validation, and continuous improvement.
• Partner with Design Engineering, Quality, Regulatory, and Program Management on new product introduction, design transfer, and manufacturing scale-up.
• Oversee production planning, material availability, inventory management, supplier performance, and supply continuity.
• Manage budgets, staffing, capital projects, performance metrics, audits, corrective actions, and organizational development.

Requirements

• Bachelor's degree in Mechanical, Manufacturing, Electrical Engineering, or a related engineering discipline.
• At least 10 years of progressively responsible experience in medical device manufacturing or operations.
• At least 5 years of leadership experience managing manufacturing operations, supply chain, and/or engineering teams.
• Experience with manufacturing engineering, production operations, supply chain management, quality systems, process validation, equipment qualification, manufacturing scale-up, and design transfer.
• Experience managing budgets, capital projects, resource plans, and operational performance metrics.
• Ability to work from the Irvine, California office and travel up to 20%, including internationally.

Nice to have

• Experience leading operations in a Class II or Class III medical device environment.
• Knowledge of FDA Quality System Regulation, ISO 13485, and 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, communication, problem-solving, and team leadership skills.

Culture & Benefits

• Mission-driven, collaborative environment with significant ownership and impact.
• Comprehensive medical and dental coverage.
• FSA and HSA plan options, including an annual company HSA contribution.
• 401(k) program with employer match.
• Vacation accrual and paid holidays.