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.

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!

*User must be carb aware.

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Summary/Objective:

The Principal Manufacturing Engineer at Beta Bionics will serve as a key leader in the design, development, and optimization of advanced manufacturing processes, ensuring efficiency, regulatory compliance, and innovation in medical device production. This role will be instrumental in strategic planning, cross-functional collaboration, and driving continuous improvement initiatives aligned with ISO 13485 standards. The Principal Manufacturing Engineer will act as a mentor and technical authority, influencing best practices across the organization while ensuring product quality, cost-effectiveness, and scalability.

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]

• Strategic Process Development and Optimization :
  • Lead the development, validation, and implementation of innovative manufacturing processes for medical devices in compliance with ISO 13485 and FDA regulations.
  • Develop long-term manufacturing strategies to improve quality, efficiency, and scalability, aligning with business objectives.
  • Identify opportunities for automation and digital manufacturing to enhance production capabilities.
• _ Quality and Regulatory Compliance_ : * Establish and enforce compliance with Good Manufacturing Practices (GMP), ISO 13485 standards, and FDA regulations. * Oversee risk management and ensure robust design transfer methodologies for new product introductions. * Develop and maintain high-level manufacturing documentation, including standard operating procedures (SOPs) and work instructions.
• _ Supplier and Material Management_ : * Evaluate and approve suppliers based on quality standards, capacity, and manufacturing capabilities. * Collaborate with suppliers to qualify materials and processes, ensuring they meet stringent regulatory and company standards. * Lead supplier development initiatives to ensure long-term reliability and cost-effectiveness.
• ** Cross-Functional Leadership & Collaboration**: * Act as a senior technical resource, providing guidance and strategic direction across engineering, R&D, quality, and operations teams. * Establish and foster strong relationships with internal and external stakeholders, ensuring seamless integration of new processes into manufacturing. * Serve as a key liaison for executive leadership, providing insights on manufacturing capabilities, constraints, and opportunities.
• ** Project Management & Continuous Improvement**: * __Lead and manage high-impact engineering projects, ensuring successful execution within budget and timeline constraints. * Utilize Lean Six Sigma methodologies to drive continuous improvement, cost reduction, and waste elimination across manufacturing operations. * Champion a culture of technical excellence, fostering creativity and innovation in process development.
• _ ** Training & Mentorship**_: * Provide leadership and mentorship to junior and senior manufacturing engineers, developing talent and fostering career growth. * Conduct training programs for manufacturing teams, ensuring adherence to best practices and regulatory compliance.

Required Education and Experience

• Bachelor's Degree in Mechanical, Manufacturing, or Industrial Engineering (Master's preferred).
• 10+ years of experience in a medical device manufacturing environment, or other regulated industry.
• Proven experience leading complex manufacturing projects and cross-functional teams.
• Deep expertise in Lean manufacturing, Six Sigma, and process validation.
• Proficiency in CAD, parametric modeling, and manufacturing simulation tools.
• Strong analytical, problem-solving, and decision-making skills

Work Environment and Personal Protective Equipment

• Professional office and manufacturing environments; occasional lab or field work requiring personal protective equipment.
• Personal Protective Equipment (PPE) may be required for specific tasks at Beta Bionics, including but not limited to safety glasses, gloves, lab coats, and hearing protection.

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 up to 20% depending upon business needs.

Location

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

Salary Range

$130,000 - $180,000

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.