Sr. Product Development Engineer I

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 the "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 Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. But we're 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. Because many of our own team members live with 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:

The Sr PDE at Tandem is also responsible for:

• Participates as an integral member of a team developing and implementing cannula components for insulin infusion sets, including soft cannula designs, insertion mechanisms, and interfaces with infusion set tubing.
• Drives the development and optimization of plastic molded and extruded parts, ensuring high precision and biocompatibility for subcutaneous delivery.
• Partners with suppliers and contract manufacturers to develop and qualify molds, extrusion dies, and cannula forming processes.
• Manages development and testing at external test facilities/vendors.
• Collaborates with cross-functional teams including mechanical design, manufacturing, quality, and regulatory to ensure robust and compliant product development.
• Conducts feasibility studies, material selection, and tolerance analysis for cannula and related components.
• Supports design verification and validation activities, including mechanical, dimensional, and functional testing of cannula assemblies.
• Plans, designs, develops, and/or modifies test fixtures and equipment.
• Selects components and equipment based on analysis of requirements as well as component specifications and reliability.
• Utilizes root cause investigation methodologies to de-bug and solve design performance challenges.
• Designs and runs experiments, analyzes and summarizes data, and reports the results and conclusions.
• Authors and maintains technical documentation including design specifications, test protocols, and risk analyses in compliance with FDA and ISO standards.
• Participates in design reviews, FMEA sessions, and continuous improvement initiatives.
• Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.

WHAT YOU'LL NEED:

• Bachelor's degree in mechanical engineering, Biomedical Engineering or related field, or equivalent combination of education and applicable job experience.
• 4+ years of product development experience in the medical device field.
• Proven experience in/with the following:
  • Start-up environment, demonstrating adaptability, innovation, and the ability to thrive in a fast-paced setting.
  • Plastic injection molding and extrusion, particularly for small, high-precision components.
  • Driving process development and scale-up with both internal and external manufacturing partners.
  • Insulin infusion sets or other drug delivery systems involving cannulas or catheters.
  • DOE, statistical analysis tools (e.g., Minitab), and root cause analysis.
  • External manufacturing partners and suppliers.
• Strong track record of taking initiative and driving projects from concept to completion in a dynamic, entrepreneurial atmosphere.
• Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals.
• Able to make and prioritize process and resource decisions based on overall team needs.
• Excellent communication, problem-solving, and project management skills.
• Able to communicate technical knowledge to varying levels within organization.
• Able to work effectively in a team environment at all levels within the organization.
• Able to alter behavior and opinions considering experimental data and business need.
• Strong medical device design and product development skills.
• Strong understanding of cannula design, subcutaneous delivery, and related biocompatibility considerations.
• Proficiency in CAD software (e.g., SolidWorks) and tolerance stack-up analysis.
• Familiarity with design controls and regulatory requirements (FDA 21 CFR Part 820, ISO 13485).
• Knowledge of polymer materials used in medical applications (e.g., TPU, TPE, PEBA).
• Knowledge of Good Documentation Practices (GDP).

WHEN & WHERE YOU'LL WORK:

This is a hybrid position based in Irvine, CA with approximately 60% of non-travelling time spent in office. This position may require up to 75% travel to vendor sites depending where projects are in the development cycle and will require frequent travel to Tandem's San Diego area facilities (Headquarters and Barnes Canyon).

COMPENSATION & BENEFITS:

The starting base pay range for this position is $108,600 - $130,000 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.

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!

YOU SHOULD KNOW:

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the California Fair Chance Act, and other similar, applicable state and local laws. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information.

Tandem has good cause to conduct a review of criminal history for this position as this position will have access to customer's protected health information and regular contact with customers. 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

WHY YOU'LL LOVE WORKING HERE:
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.

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

APPLICATION DEADLINE:
The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.

#LI-Hybrid #LI-Onsite #LI-DW1