Sr. Medical Device Engineer II (Electro-Mechanical)

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 a “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 t:slim X2 insulin pump with Control-IQ technology. We’re also 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. Since 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 tandemdiabetes.com.

A DAY IN THE LIFE:

Standard working hours: M-F, 9-5p PST

Position will be held onsite (High Bluff HQ)

As a member of the product development team, the Sr. Medical Device Engineer (Electro-Mechanical) II will take on a lead role in the design and development of the Company’s next-generation medical devices, accessories, and associated test and assembly fixtures. This team member is expected to be a leading contributor to the hardware development and support the team through the design development process including all aspects of design verification and validation and transfer of development projects to production.

• Leads the design and development of electro-mechanical components and systems for the Company’s medical devices.
• Performs competitive product analysis and contributes to the development of product requirements.
• Conducts mechanical design of medical devices and fixtures using SolidWorks.
• Builds and assesses mechanical designs using rapid prototyping technologies.
• Manages execution and documentation of design verification and validation testing.
• Leads others through the process of design, development, and verification of mechanical systems.
• Writes detailed and easily understood work instructions, test protocols, and test reports.
• Develops design verification test methods.
• 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.
• Designs components for reliability/robustness.
• Responsible for characterizing, specifying, and testing component materials.
• Research applicable patents and collaborates with the intellectual property team to assess intellectual property constraints for freedom to operate.
• Research and reviews applicable standards and regulatory guidance documents related to products in development.
• Assists the Regulatory team in preparing regulatory submissions and supporting them while the product is under review.
• Works closely with the Quality Engineering team to develop and update Risk Assessments.
• Takes part in assessing vendor capabilities.
• Supports transfer of design to production.
• Leads development and implementation of design solutions needed on existing products to meet business needs.
• Independently plans and manages tasks and design and development projects.
• Represents the development team in cross functional team meetings and provides project updates.
• Confirms completion of required training plan before assuming job responsibilities.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Other responsibilities as assigned.

YOU’RE AWESOME AT:

• 8 plus years of medical device product development including detailed design, design testing, test documentation, and prototype fabrication of medical devices.
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering or equivalent combination of education and applicable job experience.
• Demonstrated proficiency in mechanical design and development of medical devices.
• Skilled at leading team through design and development process.
• Proficient with SolidWorks PDM, and analysis tools.
• Experience in material selection for polymers and metals.
• Familiar with testing methodology and data collection in a development environment.
• Python experience in hardware development valuable.
• Ability to collaborate with suppliers in design for manufacturability and for tooling and automation.
• Experience in material selection for polymers and metals.
• Demonstrated proficiency in injectio