Staff Product Development Engineer

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:

Beta Bionics is seeking a Staff Product Development Engineer with strong medical device experience, particularly in process development for complex electromechanical systems. This individual will play a key technical leadership role in the design, development, and commercialization of next-generation insulin pump systems. The ideal candidate thrives in a fast-paced, collaborative environment and brings a solid background in regulated product development from concept through production.

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]

• Lead and execute development efforts for subsystems and components of insulin pump platforms, with a strong emphasis on design for manufacturability (DFM) and process development.
• Define, develop, and optimize manufacturing and assembly processes to ensure product quality, reliability, and cost-effectiveness.
• Collaborate cross-functionally with Systems Engineering, Quality, Regulatory, Manufacturing, and Clinical teams to define product requirements, risk mitigations, and verification/validation strategies.
• Develop process characterization, support validation plans (IQ/OQ/PQ), and ensure compliance with ISO 13485 and FDA QSR requirements.
• Work closely with suppliers and contract manufacturers to develop and scale manufacturing processes, including fixture design, process controls, and test methods.
• Generate and review DHF documentation, including design inputs/outputs, test protocols, and reports.
• Serve as a technical mentor and thought leader within the engineering team; support junior engineers and cross-functional training initiatives.
• Contribute to root cause analysis and CAPA investigations when necessary.

Required Education and Experience

• B.S. or M.S. in Mechanical Engineering, Biomedical Engineering, or related field.
• 7+ years of experience in medical device product development, preferably Class II or III devices.
• Proven experience in process development, including assembly techniques, bonding, sealing, and manufacturing automation.
• Deep understanding of design controls, risk management (ISO 14971), and quality systems (ISO 13485, FDA 21 CFR 820).
• Experience working with electromechanical or fluid-handling systems in a regulated environment.
• Demonstrated ability to develop scalable, robust manufacturing processes and drive process validation activities.

Preferred Experience and Qualifications

• Experience with insulin delivery systems, infusion pumps, or other wearable drug delivery devices.
• Experience in design for Six Sigma (DFSS), Lean manufacturing, or statistical process control (SPC).
• Proficiency in CAD (e.g., SolidWorks), FMEA, and root cause analysis tools (e.g., 8D, Fishbone, 5 Whys).

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.
• This job requires utilization of laboratory equipment.

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.

Salary Range

$155,000 - $185,000

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.