Product Development Engineer II

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.

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A Product Development Engineer II at Tandem is responsible for technical contributions to the development, documentation, testing, analysis, troubleshooting, and debugging of Tandem's new medical devices, test and assembly fixtures, and data collection systems.

• Participates in the research, development, modification, and reliability evaluation of medical device components and systems, applying engineering principles and knowledge of materials and component properties.
• Conducts mechanical design of medical devices and fixtures using Solid Works, including rapid prototyping, design assessment, and tolerance analysis of parts and assemblies.
• Manages design verification and validation activities, including development of work instructions, test protocols, and test reports, and maintenance of associated documentation.
• Investigates and resolves design non-conformances and assembly process issues using root cause analysis and troubleshooting methodologies.
• Plans, designs, develops, and evaluates fixtures, equipment, and assembly processes, including CNC‑machined components with consideration for manufacturability, machining limitations, and inspection requirements.
• Drives the design, development, qualification, and operational documentation of medical device pilot assembly lines.
• Designs and executes experiments, performs statistical analysis to evaluate process capabilities, and communicates results and conclusions.
• Participates in reviews of requirements, data, and process validation protocols/reports.
• Creates and reviews engineering drawings as needed using Solid Works.
• Selects components and equipment based on analysis of requirements as well as component specifications and reliability.
• Develops and manages development and testing at external test facilities/vendors as well as reviewing and assessing vendor capability to support development.

This role is on-site five days a week at our San Diego office due to the nature of the work involved.

• Bachelor’s degree in mechanical engineering, biomedical engineering or related field or equivalent combination of education and applicable job experience.
• 2 years of product development experience in a heavily regulated industry, preferably in medical device.
• Ability to work effectively in a team environment and communicate technical knowledge to varying levels within organization.
• Exposure to testing methodology and data collection in a development environment is valuable.
• Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
• Excellent written communication skills and experience with MS Office.
• Able to utilize statistical analysis techniques and tools to summarize data and support conclusions.
• Able to alter…