Sr Product Development Engineer II

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 type 1 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 on-site five days a week at our headquarters in Del Mar due to the nature of the work involved.

A DAY IN THE LIFE:

The Senior Product Development Engineer II plays a key leadership role within the product development team, driving the design and development of the Company’s new and existing products, including insulin pumps, disposables, and accessories. This role involves leading hardware development efforts and guiding the team through the entire design and development process, from defining design requirements, and generating innovative ideas to detailed design, analysis, design verification, validation, and successful transfer of projects to manufacturing operations. 

Senior Product Development Engineers at Tandem also:

• Lead the design & development of mechanical components and systems for the Company’s medical devices.
• Conduct research and literature reviews to identify and integrate new technologies into product designs and processes.
• Collaborate with clinical experts to improve patient experience and product performance.
• Perform competitive product analysis and contribute to defining product requirements.
• Lead technical reviews of design requirements, data, design, and verification/validation reports.
• Design medical devices and fixtures using SolidWorks.
• Guide and mentor team members through the design, development, and verification of mechanical systems.
• Define appropriate tolerances and perform tolerance analysis for parts, components, and assemblies.
• Develop and implement new assembly processes and verify their effectiveness as required.
• Apply root cause investigation methodologies to debug and resolve design and process challenges.
• Lead and participate in formal and informal design reviews.
• Utilize rapid prototyping technologies to build and evaluate mechanical designs.
• Manage design verification and validation activities, including build plans, traceability documentation, test protocols, and test reports.
• Create detailed, clear, and actionable work instructions, test protocols, and reports.
• Develop test methods and perform design verification testing.
• Assess vendor capabilities to ensure alignment with project requirements.
• Support the seamless transfer of designs and processes to manufacturing operations.
• Serve as a subject matter expert, leading the development and implementation of design solutions for existing products to address business needs.
• Independently plan and manage tasks and development projects with minimal supervision.
• Represent the development team in cross-functional meetings and provide regular project updates.
• Ensure completion of required training plans before assuming responsibilities.
• Maintain compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

WHAT YOU’LL NEED:

• Proven expertise in mechanical design and development of medical devices.
• Skilled at leading teams through the design and development process.
• Proficient in design and analysis using SolidWorks software.
• Knowledgeable in testing methodologies and data collection in a development environment.
• Extensive experience with injection-molded part design and managing mold tooling development.
• Strong background in design transfer to manufacturing and sustaining engineering.
• Proficient in determining part tolerances and performing tolerance analysis for assemblies and processes.
• Experienced in vendor management and project coordination.