Sr. Medical Device Engineer I (Electro-Mechanical) 3x openings

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 Senior Product Development Engineer I will take on a lead role in the design and development of the Company’s next-generation medical devices, accessories, test and assembly fixtures, and data collection systems.

• Develops the Company’s next-generation medical devices and accessories.
• Creates subsystem requirements, architecture, and engineering specifications.
• Mechanical design of product and fixture assemblies, parts, and drawings using SolidWorks.
• Builds and assesses mechanical designs using rapid prototyping technologies.
• Performs competitive product analysis and contributes to the development of product requirements.
• Creates engineering drawings in accordance with ASME Y14.5 GD&T standard.
• Conducts tolerance stack-up analysis for both parts and assemblies.
• Drafts and executes both test method validation and design verification testing.
• Writes detailed technical reports summarizing test results and experimental design.
• Troubleshoots product design and assembly tooling and processes.
• Responsible for characterizing, specifying, and testing component materials.
• Selects components and equipment based on analysis of requirements as well as component specifications and reliability.
• 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.
• Develops and delivers training for other engineers, technicians, and operators.
• Confirms completion of required training plan before assuming job responsibilities.
• Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
• Other responsibilities as assigned.

YOU’RE AWESOME AT:

• 5 years of product development experience in the medical device field including detailed design, design testing, test documentation, and prototype fabrication of medical devices.
• Bachelor’s degree in mechanical engineering, biomedical engineering or related field or equivalent combination of education and applicable job experience.
• Previous experience designing small, complex parts and assemblies using SolidWorks.
• Demonstrated proficiency in designing injection molded parts and assemblies
• Exposure to testing methodology and data collection in a development environment.
• Experience using electronics test equipment such as oscilloscope, logic analyzer and DMM.
• Proven ability to set up a bench test to collect some data (both HW and SW development).
• Ability to analyze data with statistical reasoning using Python and Excel.
• Ability to program in Python for hardware test development.
• Experience in specifying and analyzing part and assembly tolerances
• Demonstrated proficiency in writing test methods, protocols, and reports.
• Ability to clearly communicate ideas and persuade others through consolidating, evaluating, and presenting relevant information.
• Excellent written and verbal communication skills.
• Strong understanding of statistics and tools to summarize data and support conclusions.
• Ability to work effectively in a team environment at all levels within the organization.
• Working knowledge of federal and other regulations, e.g., QSRs, ISO 14971 IEC 60601 series.
• Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and Good Documentation Practices (GDP).
• Proficient with SolidWorks software, PDM, and analysis tools.

WHAT’S IN IT FOR YOU?

In addition to innovative tech