Sr Product Development Engineer II

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 type 1 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 on-site five days a week at our headquarters in Del Mar due to the nature of the work involved.

A DAY IN THE LIFE:

The Senior Product Development Engineer II plays a key leadership role within the product development team, driving the design and development of the Company’s new and existing products, including insulin pumps, disposables, and accessories. This role involves leading hardware development efforts and guiding the team through the entire design and development process, from defining design requirements, and generating innovative ideas to detailed design, analysis, design verification, validation, and successful transfer of projects to manufacturing operations. 

Senior Product Development Engineers at Tandem also:

• Lead the design & development of mechanical components and systems for the Company’s medical devices.
• Conduct research and literature reviews to identify and integrate new technologies into product designs and processes.
• Collaborate with clinical experts to improve patient experience and product performance.
• Perform competitive product analysis and contribute to defining product requirements.
• Lead technical reviews of design requirements, data, design, and verification/validation reports.
• Design medical devices and fixtures using SolidWorks.
• Guide and mentor team members through the design, development, and verification of mechanical systems.
• Define appropriate tolerances and perform tolerance analysis for parts, components, and assemblies.
• Develop and implement new assembly processes and verify their effectiveness as required.
• Apply root cause investigation methodologies to debug and resolve design and process challenges.
• Lead and participate in formal and informal design reviews.
• Utilize rapid prototyping technologies to build and evaluate mechanical designs.
• Manage design verification and validation activities, including build plans, traceability documentation, test protocols, and test reports.
• Create detailed, clear, and actionable work instructions, test protocols, and reports.
• Develop test methods and perform design verification testing.
• Assess vendor capabilities to ensure alignment with project requirements.
• Support the seamless transfer of designs and processes to manufacturing operations.
• Serve as a subject matter expert, leading the development and implementation of design solutions for existing products to address business needs.
• Independently plan and manage tasks and development projects with minimal supervision.
• Represent the development team in cross-functional meetings and provide regular project updates.
• Ensure completion of required training plans before assuming responsibilities.
• Maintain compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

WHAT YOU’LL NEED:

• Proven expertise in mechanical design and development of medical devices.
• Skilled at leading teams through the design and development process.
• Proficient in design and analysis using SolidWorks software.
• Knowledgeable in testing methodologies and data collection in a development environment.
• Extensive experience with injection-molded part design and managing mold tooling development.
• Strong background in design transfer to manufacturing and sustaining engineering.
• Proficient in determining part tolerances and performing tolerance analysis for assemblies and processes.
• Experienced in vendor management and project coordination.
• Excellent communication skills, with the ability to convey technical concepts to diverse audiences within the organization.
• Thorough understanding of Good Documentation Practices (GDP).
• Exceptional written communication skills for clear and effective documentation.
• Proficient in using statistical techniques and tools to analyze data and support conclusions.
• Strong ability to collaborate and work effectively in team environments across all organizational levels.
• Experienced with MS Office and related productivity tools.
• Proven expertise in mechanical design and development of medical devices.
• Skilled at leading teams through the design and development process.
• Proficient in design and analysis using SolidWorks software.
• Knowledgeable in testing methodologies and data collection in a development environment.
• Extensive experience with injection-molded part design and managing mold tooling development.
• Strong background in design transfer to manufacturing and sustaining engineering.
• Proficient in determining part tolerances and performing tolerance analysis for assemblies and processes.
• Experienced in vendor management and project coordination.
• Excellent communication skills, with the ability to convey technical concepts to diverse audiences within the organization.
• Thorough understanding of Good Documentation Practices (GDP).
• Exceptional written communication skills for clear and effective documentation.
• Proficient in using statistical techniques and tools to analyze data and support conclusions.
• Strong ability to collaborate and work effectively in team environments across all organizational levels.
• Experienced with MS Office and related productivity tools.
• Bachelor’s degree in Biomedical Engineering, or a related field, or an equivalent combination of education and relevant job experience.
• Advanced coursework, a master’s degree in engineering, professional licensure, or relevant certifications are preferred.

   

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 are firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value 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.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $126,200 - $158,000 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, 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 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.

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 : $126,200 - $158,000