Tandemdiabetes

Sr Design Quality Engineer I - Hardware

California - CapBio Irvine · Senior · Contract

No sponsorship$109k-$125kDetected 20 days ago

AlgorithmsComplianceProduct ManagementGD&TMechanical DesignHIPAAFDA RegulatoryMedical DevicesLeadershipRegulatory Affairs

About the role

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.
WHEN & WHERE YOU'LL WORK: Hybrid: This role will be a mix of in-office work at our Irvine Office and remote work.
This position is expected to be in office 2-3 days per week but may vary depending on business demands.

Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin.
As a key Quality leader partnering closely with R&D, Regulatory Affairs, Clinical, Manufacturing, and Supplier Quality teams, this role provides quality leadership across the full product lifecycle, from concept and product launch through sustaining engineering and post-market support.
The position drives robust Design Controls and Risk Management practices for complex electro-mechanical systems and consumables, while working independently to optimize and continuously improve quality system processes and internal operations to ensure conformance to specifications, effective risk reduction, and continuous improvement of both device quality and business performance.

5+ years of experience working as a Quality Engineer in an FDA-regulated industry within design and development (equivalent experience will be considered).
Working knowledge of mechanical drawings and specifications, including interpretation of geometric dimensioning and tolerancing (GD&T).
deep hands‑on manufacturing expertise is not required.
This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.
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.

Ensures compliance with company policies, including Privacy/HIPAA, and all applicable regulatory, legal, and safety requirements.

The starting base pay range for this position is $109,000 - $125,000 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 and a robust benefits package.
You'll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan.

In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package.
Tandem offers health care benefits such as medical, dental, vision available your first day, as well as 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 (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan.
Learn more about Tandem's benefits here!
Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience.

At Tandem, we believe joy fuels excellence.
That's why we've built a workplace that celebrates your achievements and supports your well-being.
Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie.
This is just one of the ways we stay awesome!
Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.
BE YOU, WITH US!
We embrace the value that every single one of us brings 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.
Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation.
We are an inclusive organization, and we welcome applications from a wide range of candidates.
Selection for roles will be based on individual merit alone.
We love a good referral!

equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation.

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.

This listing is sourced directly from Tandemdiabetes's careers page and normalized into a canonical job model.