Sr. Mechanical Engineer (Disposables)

Sr. Mechanical Engineer (Disposables)

About Beta Bionics

Beta Bionics, Inc. is a medical technology company working to commercialize the world’s first bionic pancreas called the iLet®. The iLet bionic pancreas is a wearable investigational device designed to autonomously control glucose in people with diabetes or other conditions of glycemic dysregulation.


Fueled by investments from high-profile funds and strategic partners and leveraging technology backed by years of clinical data, we are now entering a tremendously exciting phase in our development as we prepare to begin our large pivotal clinical trial and anticipated commercialization of the iLet bionic pancreas.


Beta Bionics is a public benefit corporation. This means we are a for-profit company with obligations to serve both our public benefit mission and shareholders’ interests. Beta Bionics is also a certified B Corporation; and as such accountable to operate with high standards of transparency, sustainability and accountability to our customers, employees, business partners, society, and the environment.


Successful candidates will be working with highly experienced colleagues, who are amongst the best in their fields and dedicated to bringing to market our truly disruptive technology. 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 us on this journey to achieve Beta Bionics’ bold commitment to the millions of people waiting for the iLet bionic pancreas!


Sr. Mechanical Engineer (Disposables)

Responsible to design, analyze, develop, and verify single use injection molded sterile medical devices. 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. The Sr. Mechanical Engineer, Disposables performs a variety of duties that involves engineering analysis, design and problem solving.


Location and Travel

This position is based at our Irvine CA location and may require up to 15% travel as needed


Key Job Responsibilities

· Lead development of high-volume single use injection molded products

· Personally execute mechanical design activities as required (CAD, engineering analysis, documentation)

· Work effectively with multi-disciplinary design teams to ensure integration of all stakeholder inputs

· Support company goals and objectives, policies and procedures, Design Controls, and FDA regulations including compliance to EN ISO 13485, Medical Device Quality Standards

· Ensure that all regulatory and internal policies are followed

· Make 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

· Demonstrate accuracy, thoroughness and monitors own work to ensure quality

· Special projects will require extended work hours and some travel may be required


Required Education and Experiences

· 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 Solidworks.

· Ability to work well with others in a cross-functional team environment.


Minimum certifications/educational level:

Bachelor’s Degree in Mechanical or Biomedical Engineering (An advanced degree in Mechanical or Biomedical Engineering preferred)


Minimum experience:

5+ years of experience, ideally within in a medical device environment


Benefits

• Training and mentorship with ongoing learning and development courses

• Comprehensive medical and dental coverage

• 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.


How to Apply

If you are interested in the position, please submit your resume to HR@betabionics.com.


Authorization to work in the United States is a precondition to employment in this position. Beta Bionics will not sponsor candidates for work visas for this position.

CAUTION: The iLet® bionic pancreas is an investigational device limited by Federal (or United States) law to investigational use. Not available for sale.

© 2021 Beta Bionics, Inc. Beta Bionics® and iLet® are registered trademarks of Beta Bionics, Inc. All rights reserved. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation.