Director, Operations

Beta Bionics, Inc.•Irvine, CA

12d•$170,000 - $230,000•Hybrid

About The Position

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!

Requirements

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.

Nice To Haves

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.

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.
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.