Sr Product Development Engineer I

GROW WITH US:  

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME:

Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control  -IQ technology — an advanced predictive algorithm that automates insulin delivery.

But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at https://www.tandemdiabetes.com/

WHEN & WHERE YOU’LL WORK:

On-Site: This role is typically on-site five days a week at our Irvine office due to the nature of the work involved. Occasional travel to San Diego may also arise. 

Travel: This role may require car and air travel up to 10% of time including potential international travel.

A DAY IN THE LIFE:

As a member of the product development team, the Sr. Product Development Engineer I will be a key contributor to the design and development of the Company’s new insulin delivery disposables.  This team member is expected to contribute to the hardware development and support the team through the design development process, including all aspects of feasibility, design verification and validation, and transfer of development projects to production. 

A Sr. Product Development Engineer at Tandem also: 

• Contributes to the design & development of mechanical components and systems for the Company’s disposable medical devices.
• Leads development and implementation of design solutions to meet business needs.
• Leads development and implementation of specialized components for use in disposable medical devices.
• Works with internal and external resources to develop new methods to manufacture components of Tandem’s disposable medical devices.
• Finds, assesses, and manages vendors for specialized components for use in medical devices.
• Develops and performs feasibility tests for new or updated medical device components and assemblies.
• Works with cross functional teams to integrate new components, assemblies, and processes into Tandem QA, OPs, and Supply Chain.
• Supports scale-up and transfer to production for components and assemblies of disposable medical devices.
• Manages design verification and validation planning including build plans, traceability documentation, test protocols, test reports, etc.
• Writes detailed and easily understood work instructions, test protocols, and test reports.
• Develops test methods and performs design verification testing.
• Utilizes root cause investigation methodologies to de-bug and solve design performance challenges.
• Performs tolerance analysis of parts and mechanical designs.
• Leads technical review of design requirements, data, design, and verification/validation reports
• Confirms completion of required training plan before assuming job responsibilities.
• Provides support and guidance to other engineers for device design, development, and testing.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Participates in project and department planning.
• May supervise technicians or junior level engineers.

WHAT YOU’LL NEED:

• Bachelor’s degree in mechanical engineering, Biomedical Engineering or equivalent combination of education and applicable job experience.
• Master's degree preferred.
• 5 years of medical device product development experience.
• Experience with material science or material selection heavily preferred. 
• Proven experience in a start-up environment, demonstrating adaptability, innovation, and the ability to thrive in a fast-paced setting.
• Strong track record of taking initiative and driving projects from concept to completion in a dynamic, entrepreneurial atmosphere.
• Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs.
• Demonstrated proficiency in mechanical design and development of medical devices.
• Skilled at eff