Beta Bionics

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:

We are seeking a hands-on and agile Director of Mechanical Engineering to lead the design, development, and manufacturing support of durable medical devices. This role demands strong technical skills, leadership by example, and the ability to move quickly to identify and resolve issues. The ideal candidate is a doer as much as a strategist—able to work shoulder-to-shoulder with the team in solving problems, improving processes, and driving results in a fast-paced, evolving environment.

Primary 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]

• Lead mechanical engineering design and development for medical devices with direct, hands-on involvement in CAD, analysis, prototyping, and debugging.
• Lead and manage the development of complex electro-mechanical and consumable drug delivery devices, including full lifecycle ownership: concept, design, drug compatibility, verification, regulatory submission, manufacturing support, and product launch.
• Serve as a technical lead for fast resolution of product and process issues—jumping in personally to diagnose root causes and drive effective corrective actions.
• Lead by doing—step in to help when and where needed, whether it’s design reviews, on-the-floor troubleshooting, or supplier discussions.
• Partner closely with manufacturing, quality, and supply chain teams to ensure smooth transition from design to production and to quickly resolve any production challenges.
• Build and lead a high-performing mechanical engineering team with a focus on agility, ownership, and results.
• Collaborate with cross-functional teams to ensure robust system integration across hardware, software, clinical, and regulatory inputs.
• Ensure all engineering activities meet FDA regulations, ISO 13485, and company Design Control requirements.
• Lead concurrent projects while managing shifting priorities, compressed timelines, and the demands of a dynamic start-up environment.
• Foster a culture of speed, accuracy, and continuous improvement through strong leadership and hands-on engagement.
• Maintain clear, concise, and detailed documentation of engineering decisions, risk assessments, and design outputs.

Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering.
• 10+ years of mechanical engineering experience, with 5+ years in leadership roles within regulated industries—medical device experience strongly preferred.
• Proven track record of solving complex product and process issues quickly and effectively.
• Strong background in mechanical design (CAD, tolerance analysis, materials), product testing, and manufacturing support.
• Deep knowledge of medical device development under FDA and ISO 13485 requirements.
• Hands-on experience with manufacturing methods such as injection molding, machining, DFM/DFA practices.
• Excellent interpersonal skills; able to build trust, lead by example, and influence across disciplines.
• Thrives in fast-moving environments; embraces ambiguity and adapts quickly to change.
• Willingness to be on-site, at vendors, or on the production line to solve problems firsthand.

Work Environment and Personal Protective Equipment

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and scanners.

Physical Demands

• While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with co-workers.
• This position requires travel depending upon business needs.

Location

• This position is based out of our office in Irvine, California or San Diego, California.

Salary Range

$240,000 - $280,000

Benefits

• Comprehensive medical and dental coverage
• FSA and HSA Plan Options, including an annual company contribution to the HSA
• 401(k) program with employer match
• Generous vacation accrual and paid holiday schedule

Equal Employment Opportunity Statement

It is the policy of Beta Bionics to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Beta Bionics will provide reasonable accommodations for qualified individuals with disabilities.