Engineer, Medical Device

Engineer, Medical Device

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!


Mechanical Test Engineer, Medical Device

The Medical Device Mechanical Test Engineer’s focus will be to support the design and development team by developing, writing, and executing test procedures involving performance, durability, and reliability assessments. The Medical Device Mechanical Test Engineer will also design, build, and document test fixtures involving mechanical components such as motors, gears, pumps, and pneumatic systems. The role involves working closely with internal and external cross-functional team members, understanding clinical use cases, and knowledge of the medical device design process. Applicants with strong communication and cross-functional team working skills and the ability to be proactive and work independently are highly considered.


Location

This position is based in Irvine, CA. This position may require travel up to 15%, depending upon business needs.


Key Job Responsibilities

• Develop test methods and test cases to challenge the mechanical system components including fluid delivery geared mechanisms, machined and molded parts.

• Design, fabricated, and build mechanical test systems involving custom components, equipment, and machinery.

• Develop, maintain, and conduct internal testing procedures and verification protocols.

• Generate written test reports based on outcomes and findings of executed protocols.

• Create and evaluate test fixtures needed to support manufacturing and production.

• Fabrication and modification of prototypes and testing equipment to meet product performance specifications.

• Understand device design and core technologies to develop test methods that align with product requirements.

• Determine test coverage and regression testing for design revisions to the product.

• Author test summaries and other documents.


Required Education and Experiences

• Bachelor’s Degree in Mechanical Engineering or other applied science degree.

• 8 years in a medical device environment.

• Experience designing mechanical test systems using motors, gears, fluid flow monitoring equipment

• Must be able to read and interpret mechanical drawings and electrical schematics.

• Ability to apply the principles outlined in Quality System Regulations (QSRs/GMPs).

• Knowledge and deep understanding of engineering fundamentals

• Demonstrated problem-solving ability and techniques

• Must have excellent verbal and written communication skills

• Ability to use necessary hand tools such as drills, soldering irons, micrometers, calipers, and other measuring devices

• Understanding principals of fluid dynamics and fluid flow for pumps and fluid delivery

• Ability to operate electrical and mechanical equipment and interpret results

• Experience creating, editing, and documenting components using Solidworks and Solidworks PDM.

• Understanding of statistics and statical process in manufacturing high volume production components


Preferred Education and Experiences

• Advanced degree preferred.

• Experience in medical device companies a plus.

• Proficiency with Microsoft Office Suite and well-known 

Enterprise Resource Planning (ERP) software.


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 40 pounds.

• Wears personal protective equipment as required.


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.

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

© 2020 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.