Senior Software Design Assurance Engineer

Senior Software Design Assurance Engineer

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!


Senior Software Design Assurance Engineer

The Senior Software Design Assurance Engineer is responsible for pre-market Design Quality Assurance related activities for the design and development of medical device software.


Location and Travel

This position is based at our offices in Irvine, CA. This position requires travel up to 10% depending upon business needs.


Key Job Responsibilities

• Design Assurance Responsibilities

  • Maintains compliance with design control activities per 21 CFR 820.30 and ISO 13485:2016.

  • Authors or provides input to design verification activities, including master verification planning, protocol development, data collection and analysis, and reporting.

  • Works with R&D for the creation of design input and output documents.

  • Performs software analysis, code review, SOUP assessment and anomaly reporting.

  • Manages software configuration control during the design cycle and transfer to manufacturing.

  • Manages design review activities related to software.

  • Ensures product requirements traceability from user needs to design verification test reporting.

  • Works within the document control system to author, route, and approve controlled documents.

  • Collaborates with the Commercial team and R&D regarding Human Factors testing.

  • Works with R&D in the development and test of software testing tools and fixtures.

  • Collaborates with R&D on software related risk management activities.

• General Duties

  • Participates in third party and internal quality audits involving areas of responsibility.

  • Establishes, maintains Standard Operating Procedures and Forms related to areas of responsibility.

  • Advises and trains other Company personnel concerning areas of responsibility.

  • Communicates information related to quality management system effectiveness.

  • Works in accordance with quality system procedures.

  • Other duties as assigned by Supervisor.


Required Education and Experience

• A Bachelor’s Degree or Higher in a software engineering or related discipline.

• Minimum four (4) years’ experience in a Software Quality role in the medical device industry.

• Experience in software verification and validation activities.


Preferred Skills and Qualifications

• Experience with software controlled electromechanical systems.

• Knowledge of software programming including the use of C-based code for medical devices including mobile applications.

• Knowledge of Part 11 requirements for electronic systems.

• Good verbal and written communication skills including ability to prepare written procedures and reports.

• Good organizational and planning skills.

• Proficient in the use of word processing (MS Word), spreadsheet (MS Excel), and document management (Adobe Acrobat) software.

• Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor.

• Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.

• Good organizational and communication skills, including ability to represent the company to both internal and external audiences.

• Proficient or able to learn how to manage internet cloud storage services such as Google Drive and/or electronic document control systems.

• Knowledge of domestic and international regulations and standards, including ISO 13485, related to medical device manufacturing.

• Knowledge of ISO 14971 for risk management of medical devices.

• Knowledge of ISO 62304 regarding software lifecycle.

• Proficiency desired with application of statistical techniques for design, manufacturing and quality systems.


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.