Senior Production Engineer

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!

[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, and Good Manufacturing Practices.
• →Ensure compliance with quality standards such as ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes and FDA 21 CFR Part 820 Quality System Regulation as well as safety regulations such as OSHA.
• →Ensure that all regulatory and internal policies are followed.
• →Makes decisions in a timely manner, based upon a mixture of analysis, wisdom, experience and judgment.
• →Monitor and analyze key performance indicators such as yield, scrap, downtime, cycle time, etc. and take corrective actions as needed.
• →Develop process improvements to effectively utilize equipment and materials to maximize production.
• →Implement continuous improvement initiatives using lean manufacturing principles and tools.
• →Troubleshoot and resolve technical issues with machinery, equipment, or software using root cause analysis and corrective action techniques.
• →Coordinate multiple project activities concurrently to achieve timeline requirements; use resources effectively and efficiently while adjusting to changing priorities in a start-up environment.
• →Collaborate with cross-functional teams such as engineering, quality, maintenance, and supply chain to support production goals.
• →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 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.
• →Other duties as assigned.

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 on-line applications.
• Ability to work well with others in a cross-functional team environment.

Minimum Certifications/Educational Level:

• Bachelor’s Degree in Mechanical, Manufacturing, Industrial, Biomedical Engineering or combination of education and applicable work experience.

Minimum Experience:

• 5-8 years of experience in a medical device environment.
• Experience in Medical Device, or Consumer Electronics.
• Experience in FDA/GMP/ISO environment.

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopier, and scanners.

• While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with co-workers.
• This position requires travel up to 5% depending upon business needs.

$95,000 - $130,000

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.