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 https://www.tandemdiabetes.com/

WHEN & WHERE YOU’LL WORK:

This role is typically on-site five days a week at our Irvine office due to the nature of the work involved. Occasional travel to San Diego may also arise. This role may require car and air travel up to 10% of time.

A DAY IN THE LIFE:

A Product Development Engineer responsible for testing, building, designing, and documenting the Company’s next-generation medical devices, test and assembly fixtures and data collection systems.

A Produce Development Engineer at Tandem also:

• Develops test methods, performs design verification testing & verifies performance with Gage R&R studies
• Writes detailed and easily understood work instructions, test protocols, test methods, and test reports and uses statistical analysis to interpret test data in support of design verification and validation
• Troubleshoots product design and assembly processes
• Participates in the development of mechanical components and systems for the company’s medical devices
• Mechanical design of test fixtures and medical devices using SolidWorks
• Builds and assesses mechanical designs using rapid prototyping technologies
• Works within design controls and contributes to the design history file for medical devices by reviewing product requirements and specifications, documenting the design process, participating in formal design reviews, and verifying the product performance with formal test methods, protocols, and reports.
• Performs competitive product analysis and contributes to the development of product requirements
• Performs tolerance analysis of mechanical designs and conducts and participates in design reviews
• Supports transfer of design to manufacturing
• Confirms completion of required training plan before assuming job responsibilities and 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 equivalent combination of education and applicable job experience.
• At least 6 months of product development experience in the medical device field.
• Experience with testing methodology, data collection, and data analysis in a development environment.
• Ability to communicate technical knowledge to varying levels within organization.
• Capable of using statistical techniques and tools to summarize data and support conclusions.
• Knowledge of Good Documentation Practices (GDP).
• Excellent written communication skills and able to work effectively in a team environment at all levels within the organization.
• Familiar with medical device design and product development.
• Familiar with mechanical design of fixtures using Solidworks.
• Familiar with part tolerances and analyzing tolerances of assemblies and processes.
• Experience with MS Office.

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. 

COMPENSATION & BENEFITS:

The starting base pay range for this position is $80,000.00 - $88,000.00 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 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.

REFERRALS:

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

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.

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-Onsite #LI-BC1

Salary : $80,000 - $88,000