Director of Manufacturing Engineering - Beta Bionics : Job Details

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:

The Director of Manufacturing Engineering is responsible for leading the team that oversees the design, analysis, development, and qualification of manufacturing processes, equipment, tooling, and fixtures. This role supports improved manufacturability, productivity, and product quality. Key responsibilities include mentoring and coaching team members, driving innovation, coordinating between internal departments, and managing cross-functional projects. This position requires strong analytical, leadership, and communication skills, as well as expertise in regulated manufacturing environments. The Director collaborates with R&D, Quality, and Operations, and plays a critical role in product and process validation activities.

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]

• Champion and support company goals, policies, and procedures, including compliance with EN ISO 13485, FDA regulations, and Good Manufacturing Practices (GMPs).
• Ensure full compliance with internal policies and external regulatory requirements.
• Drive timely and effective decision-making based on data, experience, and sound judgment.
• Lead the Manufacturing Engineering team in root cause investigations and continuous improvement.
• Manage multiple engineering projects simultaneously, ensuring alignment with business objectives.
• Optimize resources and adapt quickly to changing priorities in a dynamic, fast-paced environment.
• Foster strong professional relationships across departments and with external partners.
• Provide input on key strategic decisions impacting manufacturing operations.
• Deliver clear, concise, and timely communication to leadership and cross-functional teams.
• Demonstrate a high degree of accuracy, attention to detail, and commitment to quality.
• Uphold and advocate for a strong culture of safety.
• Participate in special projects, including extended hours and occasional travel as needed.

Required and Preferred Qualifications

• Knowledge, Skills, & Abilities:
  • Deep understanding of Quality System Regulations (QSRs), GMPs, and medical device manufacturing standards.
  • Skilled in using common hand tools and test equipment (e.g., soldering tools, micrometers, calipers).
  • Ability to read and interpret mechanical drawings and electrical schematics.
  • Proficient in Microsoft Office and other digital collaboration tools.
  • Strong project management, communication, and cross-functional team collaboration skills.
  • Comfortable working independently and taking initiative.
• Minimum Certifications/Educational Level:
  • Bachelor's Degree in Mechanical, Manufacturing, or Electrical Engineering (required).
• Minimum Experience:
  • 15+ years of experience in a medical device or similar regulated environment.
  • Experience with FDA, GMP, and ISO standards highly preferred.
  • Proven experience leading manufacturing engineering teams and driving process improvements.

SCOPE

• Collaborate closely with R&D to support new product development by leading the design, development, and validation of manufacturing processes.
• Partner with Quality and Operations to prepare and maintain production support documentation (e.g., IQ/OQ/PQ reports).
• Lead supplier qualification and manage supplier-related issues.
• Communicate project updates and status reports to leadership and stakeholders.

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. Personal Protective Equipment may be required for laboratory or field work.

Physical Demands

• While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear.
• Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
• Employee must occasionally lift and/or move up to 30 pounds.
• Wears personal protective equipment as required.
• This position requires up to ten (10%) percent travel

Location

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

Salary Range

$175,000 - $190,000

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.