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Added 3 mins ago
Senior Data Center Cost Manager - Cheyenne
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Program Manager
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Added 5 mins ago
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Veterans and Military Program Administrator
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Beta Bionics, Inc.

Sr. Manufacturing Engineer

Irvine, CA, United States

$110,000 to $135,000 USD / year

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Job details

Pay: $110,000 to $135,000 USD / year
Experience: 5-10 years of experience in a medical device environment.
Posting language: English
Posted: Jun 30, 2025

Original 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.

Please contact us if you fit the profile below and if you are interested in joining the Beta Bionics team!

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.

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More about this job

Skills

Lean manufacturing
Manufacturing processes
Multitasking
Problem solving
Regulatory compliance
Good manufacturing practices
Root cause analysis
Communication skills
Attention to detail
Technical drawings
Microsoft Office
Dassault Systemes SolidWorks
Consumer electronics
Personal protective equipment
Office equipment

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