Director of Medical Device Ops & Manufacturing

Beta Bionics Inc; Irvine (CA); Hybrid; USD 170,000 - 230,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) with employer match

Generous vacation and holidays

Job summary

Beta Bionics, Inc. in Irvine, California, is seeking a senior Operations leader to oversee Supply Chain, Production, and Production Engineering.

You will drive safety, quality, delivery, cost, and compliance goals in a regulated medical device environment, guiding scale-up, continuous improvement, and new product introductions. The role requires a decade of medical device manufacturing experience and at least five years in leadership of manufacturing operations, with strong collaboration across

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Electrical Engineering, or related engineering discipline.
• 10+ years of progressive medical device manufacturing or operations experience.
• 5+ years of leadership managing manufacturing operations, supply chain, and/or engineering teams.
• Experience with process validation, equipment qualification, manufacturing scale-up, and design transfer.
• Experience managing budgets, capital projects, resource plans, and operational performance metrics.

Responsibilities

• Directs Supply Chain, Production, and Production Engineering activities in accordance with quality system procedures.
• Leads daily manufacturing operations to ensure products are produced safely, efficiently, on schedule, and in compliance with applicable requirements.
• Develops and executes operational plans to improve quality, throughput, capacity, inventory, and cost performance.
• Partners with Design Engineering, Quality, Regulatory, and Program Management to support new product introduction, design transfer, and manufacturing scale-up.

Skills

Leadership

Manufacturing operations

Supply chain management

Quality systems

Process validation

Equipment qualification

Design transfer

Data-driven decisions

Cross-functional collaboration

Continuous improvement

Education

Bachelor's degree in Mechanical, Manufacturing, Electrical Engineering, or related

Tools

ERP

Manufacturing Execution Systems

Job description

Beta Bionics, Inc. in Irvine, California, is seeking a senior Operations leader to oversee Supply Chain, Production, and Production Engineering.

You will drive safety, quality, delivery, cost, and compliance goals in a regulated medical device environment, guiding scale-up, continuous improvement, and new product introductions. The role requires a decade of medical device manufacturing experience and at least five years in leadership of manufacturing operations, with strong collaboration across