Senior Product Development Engineer I

1 day ago

San Diego, California, United States Tandem Full time
About the Role

We are seeking a highly skilled Senior Product Development Engineer I to join our team at Tandem Diabetes Care. As a key member of our product development team, you will play a lead role in the design and development of our next-generation medical devices, accessories, and associated test and assembly fixtures.

Key Responsibilities
  • Design, develop, and verify performance of electro-mechanical components, mechanisms, and systems for our next-generation medical devices and accessories.
  • Conduct requirements analysis, architectural design, and develop detailed engineering specifications.
  • Support sustaining engineering by performing root cause analysis and developing design changes to resolve identified issues.
  • Develop benchtop fixtures to test design parameters as well as manufacturing processes.
  • Research applicable patents and collaborate with the intellectual property team to assess intellectual property constraints for freedom to operate.
  • Research and review applicable standards and regulatory guidance documents related to products in development.
  • Design components for reliability/robustness.
  • Perform tolerance analysis of parts and assemblies.
  • Responsible for characterizing, specifying, and testing component materials.
  • Select components and equipment based on analysis of requirements as well as component specifications and reliability.
  • Assist the Regulatory team in preparing regulatory submissions and supporting them while the product is under review.
  • Participate in evaluating the reliability of materials, properties, and techniques used in production.
  • Troubleshoot product design and assembly tooling and processes.
  • Work closely with the Quality Engineering team to develop and update Risk Assessments.
  • Develop and deliver training for other engineers, technicians, and operators.
Requirements
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field.
  • 5 years of experience in the medical device field, including detailed design, design testing, test documentation, and prototype fabrication of wearable biomedical devices.
  • Ability to occasionally lift and/or move up to 45 pounds.
What We Offer

In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. We reward, develop, and retain our employees, and we're committed to being an equal opportunity employer and maintaining a diverse and inclusive environment.

We offer a competitive compensation package, including bonus, equity, and a robust benefits package. Our benefits include health care benefits, paid holidays, paid time off, and access to a 401k plan with company match.

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