Senior NPI 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.

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.

Location - Irvine, CA. This is an on-site/in-person role.

Summary/Objective

The Sr. NPI Engineer serves as a pivotal liaison between Research & Development (R&D) and Operations, ensuring the seamless integration of new medical device products into manufacturing. This role emphasizes New Product Introduction (NPI) engineering, focusing on designing, analyzing, developing, and qualifying manufacturing processes, materials, tooling, and fixtures to meet production requirements while enhancing productivity and product quality. Key competencies include technical creativity, initiative, problem-solving, multitasking, and effective cross-departmental coordination.

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]

• Oversee the transition of new products from design through development to full-scale manufacturing, ensuring compliance with Quality System Regulations (QSRs), Good Manufacturing Practices (GMPs), and FDA regulations, including EN ISO 13485 standards.
• Ensure new products are designed for manufacturability, cost-efficiency, and scalability.
• Design and qualify manufacturing processes, materials, tooling, and fixtures to meet production needs while enhancing productivity and product quality.
• Develop and implement supply chain strategies that support new product introductions, including material sourcing, supplier qualification, and logistics planning.
• Perform root cause analysis to resolve production and supply chain issues promptly.
• Manage multiple project activities concurrently to achieve timeline requirements; utilize resources effectively and efficiently while adjusting to changing priorities in a dynamic environment.
• Provide guidance and leadership to junior staff to accomplish tasks and achieve goals.
• Establish and maintain professional working relationships with all levels of staff, clients, suppliers, and the public.
• Ensure all regulatory and internal policies are followed, making decisions in a timely manner based on analysis, experience, and judgment.
• Demonstrate meticulous attention to detail, ensuring accuracy and thoroughness in all work.
  Promote and practice good safety skills at all times.
• Participate in special projects that may require extended work hours and some travel.

Required Education and Experience

• Ability to apply principles outlined in Quality System Regulations (QSRs/GMPs).
• Proven experience in new product introduction within the medical device industry.
• Must be able to read and interpret mechanical drawings and electrical schematics.
• Proficient with Microsoft Office and online applications.
• Proficient with CAD software.
• Ability to work well with others in a cross-functional team environment.
• Bachelor’s Degree in Mechanical or Manufacturing Engineering, or equivalent experience.
• 5-10 years of experience in a medical device environment, preferably with direct NPI or manufacturing engineering experience.
• Experience in FDA/GMP/ISO environment.

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, photocopier, 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 50 pounds.
• Wears personal protective equipment as required.
• This position is based out of Irvine, CA.
• This position requires up to five (5%) percent travel.

Location

Irvine, CA. This is an on-site/in-person role.

Salary Range

$105,000 - $145,000

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.