Product Development Engineer II

Tandem Diabetes Care Inc.; California; On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Health benefits on day one

11 paid holidays

20 days PTO

401k with company match

Employee Stock Purchase Plan

Job summary

Tandem Diabetes Care Inc. seeks a Product Development Engineer II to contribute to the design, testing and documentation of next‑gen medical devices at our San Diego, CA site.

You will design components, run verifications, and work with vendors while maintaining regulated documentation and quality standards. The role requires a mechanical/biomedical engineering background and 2 years of product development experience in a regulated industry, with strong teamwork and communication skills.

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering or related field.
• 2 years of product development experience in a heavily regulated industry.
• Ability to communicate technical knowledge to varying levels within the organization.
• Exposure to testing methodology and data collection in development is valuable.
• Knowledge of GD&T and GDP is preferred.
• Excellent written communication skills and MS Office experience.
• Ability to present information clearly and persuade others.

Responsibilities

• Contributes to development, documentation, testing, analysis and debugging of medical devices and fixtures.
• Performs design verification and validation activities with test protocols and reports.
• Plans and evaluates fixtures and assembly processes including CNC components.
• Designs and reviews engineering drawings using SolidWorks.
• Develops and manages vendor testing and external facilities support.
• Analyzes results with statistics and communicates conclusions.

Skills

Team collaboration

Communication

Problem solving

Statistical analysis

GDP/GD&T knowledge

MS Office

Education

Bachelor's degree in mechanical or biomedical engineering

Tools

SolidWorks

Statistical analysis tools

Microsoft Office

Job description

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:

A Product Development Engineer II at Tandem is responsible for technical contributions to the development, documentation, testing, analysis, troubleshooting, and debugging of Tandem's new medical devices, test and assembly fixtures, and data collection systems.

• Participates in the research, development, modification, and reliability evaluation of medical device components and systems, applying engineering principles and knowledge of materials and component properties.
• Conducts mechanical design of medical devices and fixtures using SolidWorks, including rapid prototyping, design assessment, and tolerance analysis of parts and assemblies.
• Manages design verification and validation activities, including development of work instructions, test protocols, and test reports, and maintenance of associated documentation.
• Investigates and resolves design non-conformances and assembly process issues using root cause analysis and troubleshooting methodologies.
• Plans, designs, develops, and evaluates fixtures, equipment, and assembly processes, including CNC‑machined components with consideration for manufacturability, machining limitations, and inspection requirements.
• Drives the design, development, qualification, and operational documentation of medical device pilot assembly lines.
• Designs and executes experiments, performs statistical analysis to evaluate process capabilities, and communicates 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.
• Develops and manages development and testing at external test facilities/vendors as well as reviewing and assessing vendor capability to support development.

WHERE YOU’LL WORK:

This role is on-site five days a week at our San Diego office due to the nature of the work involved.

WHAT YOU’LL NEED:

• 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 a heavily regulated industry, preferably in medical device.
• Ability to work effectively in a team environment and communicate technical knowledge to varying levels within organization.
• Exposure to testing methodology and data collection in a development environment is 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.
• Able to utilize statistical analysis techniques and tools to summarize data and support conclusions.
• Able to alter behavior and opinions in light of new information.
• Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and Good Documentation Practices (GDP).

EXTRA AWESOME:

• Ability to use SolidWorks to create and modify engineering models and drawings.
• Has working knowledge of federal and other regulations, e.g., QSRs, ISO 14971 IEC 60601 series.
• Experience with medical device design, product development, and process development.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $85,000 to $100,000 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 applicable state and local Fair Chance laws and regulations. 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 information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. 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.

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.

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.

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California. Every role at Tandem helps create new possibilities for people living with diabetes. Discover how your skills and passion can contribute to our mission through opportunities designed for students, innovators, customer‑focused sales professionals, and global talent alike. Find your path: Internships Innovation & Engineering North America Field Sales International