Sr. Manufacturing Engineer

Beta Bionics, Inc.; Irvine (CA); On-site; USD 110,000 - 135,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental coverage

FSA/HSA with company contribution

401(k) with employer match

Paid vacation and holidays

Job summary

Beta Bionics, Inc. in Irvine, CA is seeking a Sr.

Manufacturing Engineer to lead training, development, and education of junior engineers, applying Lean manufacturing and Agile Scrum to improve processes, productivity, and product quality. The role emphasizes cross‑functional collaboration, root‑cause analysis, and the ability to read mechanical drawings, with responsibilities spanning design qualification, tooling, and fixture development for scalable production.

Qualifications

• Ability to apply Quality System Regulations (QSRs/GMPs).
• Proficient with basic hand tools (drills, soldering irons, micrometers, calipers).
• Able to operate electrical and mechanical equipment and interpret results.
• Able to read mechanical drawings and electrical schematics.
• Proficient in Microsoft Office and online applications.
• Expert proficiency in SolidWorks and CAD drawings.
• Able to work well in a cross‑functional team.

Responsibilities

• Support quality system compliance and regulatory requirements (QSRs/GMPs, FDA regulations).
• Mentor Jr. personnel and lead tasks to achieve goals.
• Ensure adherence to regulatory and internal policies.

Skills

Quality systems & GMP compliance

CAD drawing in SolidWorks

Reading drawings & schematics

Microsoft Office proficiency

Cross-functional collaboration

Education

Bachelor’s Degree in Mechanical or Manufacturing Engineering

Tools

Drills

Soldering irons

Micrometers

Calipers

Electrical testing equipment

Job description

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.

Summary/Objective:

The Sr. Manufacturing Engineer takes a leadership role in training, developing, and educating Jr. Engineers. A strong understanding of Lean manufacturing principles and their application is required. Responsible to design, analyze, develop, and qualify manufacturing processes, materials, tooling, and fixtures to meet manufacturing needs while enhancing productivity and product quality. Critical attributes and skills include technical creativity, initiative, ability to analyze problems, prioritize and negotiate priorities, use a hands‑on practical approach, multi‑tasking, and coordinating between groups within the company. Performs a variety of duties that involves engineering analysis and problem solving. Works with a cross‑functional team utilizing the Agile Scrum project planning process.

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]

• Support company goals and objectives, policies, and procedures, in compliance with our Quality System requirements, Good Manufacturing Practices, and FDA regulations including compliance to EN ISO 13485, Medical Device Quality Standards.
• Mentors Jr. Personnel and takes on a leadership role to accomplish tasks and achieve goals.
• Ensures that all regulatory and internal policies are followed.
• Makes decisions in a timely manner, based upon a mixture of analysis, wisdom, experience, and judgment.
• Perform root cause analysis to resolve issues.
• Coordinate multiple project activities concurrently to achieve timeline requirements; use resources effectively and efficiently while adjusting to changing priorities in a start‑up environment.
• Ability to establish, build and maintain professional working relationships with all levels of staff, clients, suppliers and the public.
• Ability to work with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.
• Meticulous attention to detail and meeting deadlines.
• Demonstrates accuracy, thoroughness and monitors own and other’s work to ensure quality.
• Practice and advocate good safety skills at all times.
• Special projects will require extended work hours and some travel may be required.

Required Qualifications

• Knowledge, Skills, & Abilities:
  • Ability to apply principles outlined in Quality System Regulations (QSRs/GMPs).
  • Ability to use basic hand tools such as drills, soldering irons, micrometers, calipers, etc.
  • Ability to operate electrical and mechanical equipment and interpret results.
  • Must be able to read and interpret mechanical drawings and electrical schematics.
  • Proficient with Microsoft Office and online applications.
  • Expert proficiency in Solidworks and generating CAD Drawings.
  • Ability to work well with others in a cross‑functional team environment.
• Minimum Certifications/Educational Level:
  • Bachelor’s Degree in Mechanical or Manufacturing Engineering.
• Minimum Experience:
  • 5-10 years of experience in a medical device environment.
  • Experience in Medical Device, or Consumer Electronics.
  • 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, 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 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

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

Salary Range

$110,000 - $135,000

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.