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 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 attandemdiabetes.com.

A DAY IN THE LIFE:

Responsible for technical contributions to the development, documentation, testing, analysis, troubleshooting, and debugging of the Company's new medical devices, test and assembly fixtures, and data collection systems.

• Participates in the research and development of components and systems for the Company's medical devices, utilizing knowledge of engineering theory and materials or component properties.
• Utilizes statistical analysis to understand and define process capabilities.
• Plans, designs, develops, modifies, and evaluates fixtures, equipment, and assembly processes.
• Drives the design, development, and qualification of medical device pilot assembly line.
• Designs and runs experiments, analyzes, and summarizes data, and reports the results and conclusions.
• Participates in reviews of requirements, data, and process validation protocols/reports. Creates and reviews engineering drawings as needed using SolidWorks.
• Selects components and equipment based on analysis of requirements as well as component specifications and reliability.
• Creates documentation required for qualification and operation of pilot assembly line.
• Participates in evaluating the reliability of materials, components, and systems.
• Performs and interprets troubleshooting of assembly process issues.
• Develops and manages development and testing at external test facilities/vendors.
• Participates in fixture design and process risk assessments and mitigations.
• Reviews and assesses vendor capability to support development.
• Completes 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.

YOU'RE AWESOME AT:

• Strong medical device design, product development, and process development skills.
• Ability to communicate technical knowledge to varying levels within organization.
• Exposure to testing methodology and data collection in a development environment 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.
• Capable of using statistical analysis techniques and tools to summarize data and support conclusions.
• Able to work effectively in a team environment at all levels within the organization.
• Able to alter behavior and opinions in light of new information.
• Has working knowledge of federal and other regulations, e.g., QSRs, ISO 14971 IEC 60601 series.
• Knowledge of Good Documentation Practices (GDP).
• Ability to use SolidWorks to create and modify engineering models and drawings.

EXTRA AWESOME:

• 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 the medical device field.

WHAT'S IN IT FOR YOU?

In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit https://www.tandemdiabetes.com/careers.

BE YOU, WITH US!

Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value to the table. But sometimes we forget that when we don't meet 100% of a job description's criteria - maybe you're feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $85,000 - $100,000 OR annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate's location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus, equity, and a robust benefits package.

Tandem offers health care benefits such as medical, dental, vision, health savings accounts and flexible saving accounts. You'll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (starting in year 1) and have access to a 401k plan with company match. Learn more about Tandem's benefits here!

YOU SHOULD KNOW:

Potential new employees must successfully complete a drug screen (excludes marijuana) and background check which includes criminal search, education certification and employment verification prior to hire.

REFERRALS:

We love a good referral! If you know someone that would be a great fit for this position, please share!

If you are applying for this job and live in California, please read Tandem's CCPA Notice: https://www.tandemdiabetes.com/careers/california-consumer-privacy-act-notice-for-job-applicants.

#LI-KT1 #LI-Hybrid

SPONSORSHIP:

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.