Director, Operations

About Beta Bionics

Beta Bionics, Inc. is a medical technology company dedicated to bringing innovative type 1 diabetes management solutions to the many, not the few. We are committed to bringing better access to better solutions – and a better life for those living with diabetes – with the world’s first bionic pancreas called the iLet. The iLet Bionic Pancreas is the first and only insulin delivery system that does not require carb counting*, bolusing, correction factors, or pre-set basal rates.

The only number needed to get started with the iLet Bionic Pancreas is a user’s weight – the iLet does the rest. The iLet lets users “Go Bionic” with their diabetes management.

* User must be carb aware.

Successful candidates will be working with highly experienced colleagues, who are amongst the best in their fields. We have a mission-driven, passionate and collaborative culture where you will have a high degree of empowerment and opportunity to make a significant impact.

Please contact us if you fit the profile below and if you are interested in joining the Beta Bionics team!

Summary/Objective:

Responsible for leading Supply Chain, Production, and Production Engineering to achieve safety, quality, delivery, cost, and compliance objectives. Provides strategic and technical leadership for manufacturing scale-up, operational excellence, continuous improvement, and new product introduction within a regulated medical device environment.

Essential Duties and Responsibilities

[Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company’s HR contact]

• 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.
• Provides engineering leadership for manufacturing process development, equipment selection, automation, process validation, and continuous improvement.
• Partners with Design Engineering, Quality, Regulatory, and Program Management to support new product introduction, design transfer, and manufacturing scale-up.
• Oversees production planning, material availability, inventory management, supplier performance, and supply continuity.
• Establishes and monitors key performance indicators for safety, quality, delivery, productivity, inventory, and cost.
• Develops departmental budgets, staffing plans, capital expenditure justifications, and resource recommendations.
• Leads investigations and implementation of corrective and preventive actions related to manufacturing and supplier issues.
• Ensures manufacturing processes remain validated and compliant with applicable medical device regulations, standards, and internal procedures.
• Develops organizational capability through hiring, coaching, performance management, and succession planning.
• Supports internal, customer, and regulatory audits and ensures timely completion of Operations-related corrective actions.
• Establishes and maintains Standard Operating Procedures, work instructions, and forms related to areas of responsibility.
• Works in accordance with quality system procedures.
• Other duties as assigned by Supervisor.

Required Education and Experience

• 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…