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 https://www.tandemdiabetes.com/

WHEN & WHERE YOU’LL WORK:

On-Site: 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.

Travel: This role may require car and air travel up to 10% of time including potential international travel.

A DAY IN THE LIFE:

As a member of the product development team, the Sr. Product Development Engineer I will be a key contributor to the design and development of the Company’s new insulin delivery disposables. This team member is expected to contribute to the hardware development and support the team through the design development process, including all aspects of feasibility, design verification and validation, and transfer of development projects to production.

A Sr. Product Development Engineer at Tandem also:

• Contributes to the design & development of mechanical components and systems for the Company’s disposable medical devices.
• Leads development and implementation of design solutions to meet business needs.
• Leads development and implementation of specialized components for use in disposable medical devices.
• Works with internal and external resources to develop new methods to manufacture components of Tandem’s disposable medical devices.
• Finds, assesses, and manages vendors for specialized components for use in medical devices.
• Develops and performs feasibility tests for new or updated medical device components and assemblies.
• Works with cross functional teams to integrate new components, assemblies, and processes into Tandem QA, OPs, and Supply Chain.
• Supports scale-up and transfer to production for components and assemblies of disposable medical devices.
• Manages design verification and validation planning including build plans, traceability documentation, test protocols, test reports, etc.
• Writes detailed and easily understood work instructions, test protocols, and test reports.
• Develops test methods and performs design verification testing.
• Utilizes root cause investigation methodologies to de-bug and solve design performance challenges.
• Performs tolerance analysis of parts and mechanical designs.
• Leads technical review of design requirements, data, design, and verification/validation reports
• Confirms completion of required training plan before assuming job responsibilities.
• Provides support and guidance to other engineers for device design, development, and testing.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Participates in project and department planning.
• May supervise technicians or junior level engineers.

WHAT YOU’LL NEED:

• Bachelor’s degree in mechanical engineering, Biomedical Engineering or equivalent combination of education and applicable job experience.
• Master's degree preferred.
• 5 years of medical device product development experience.
• Experience with material science or material selection heavily preferred.
• Proven experience in a start-up environment, demonstrating adaptability, innovation, and the ability to thrive in a fast-paced setting.
• 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.
• Demonstrated proficiency in mechanical design and development of medical devices.
• Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to gain cooperation of others.
• Proficient with SolidWorks software.
• Familiar with testing methodology and data collection in a development environment.
• Solid experience with injection molded part design and managing mold tooling development.
• Experience with transfer of design to manufacturing and sustaining engineering valuable.
• Experience in determining part tolerances and analyzing tolerances of assemblies and processes.
• Experience in vendor and project management.
• Ability to communicate technical knowledge to varying levels within organization.
• Knowledge of Good Documentation Practices (GDP).
• Excellent written communication skills.
• Capable of using statistical techniques and tools to summarize data and support conclusions.
• Ability to work effectively in a team environment at all levels within the organization.
• 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 $105,400 - $131,800 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.