Product Stewardship Compliance 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 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 Product Stewardship Compliance EngineerII at Tandem is also responsible for:

• Ensure material compliance with relevant global product and packaging regulatory and environmental legislations and directives (e.g., REACH Regulation, WEEE Directive, RoHS Directive, California Prop 65, Conflict Minerals, EU Medical Device Regulation, Batteries Directive) for Tandem's product portfolios.
• Review of production BOMs and maintenance of ECHA/SCIP database for list of restricted substances in Tandem products. Ensure components, packaging, and product information are accurately tracked in the appropriate databases.
• Develop compliance processes independently, including tools that support the compliance process where applicable.
• Actively monitor and review developments in compliance requirements (i.e., new and/or updated requirements that may affect product portfolios). Report periodically on the status of product compliance.
• Using clear communication, support the cross-functional teams by providing compliance guidance, and communicating compliance progress, decisions, and strategies.
• Support Regulatory Affairs team with documentation in response to regulatory agencies inquiries, including compliance certifications, declaration conformity, regulatory letters, and technical packages.
• Send campaigns to all suppliers if a new substance is added to the list of restricted substances.
• Provide inputs during any new product development activities, design changes or material changes to assess for product compliance and impact on compliance to the above directives.
• Other responsibilities as assigned.

WHEN & WHERE YOU'LL WORK:

This role will be a mix of in-office work at our Barnes Canyon site and remote work. This position is expected to be in office 3-4 days per week but may vary depending on business demands.

WHAT YOU'LL NEED:

• Bachelor's degree in science, Engineering, or equivalent combination of education and applicable job experience.
• Minimum 4 years of material compliance experience managing technical projects or programs, working cross-functionally with multiple disciplines in a medical device or manufacturing environment.
• Comfortable working in a team collaborative atmosphere.
• Able to work independently and deliver high quality work product without close supervision.
• Experience working with the global/international directives including European Union directives (such as REACh and RoHS) on electronics, packaging, and battery waste, including manufacturer's obligations.
• Experience working with external test labs to develop test plans, deliver results clearly, and schedule.
• Possess technical leadership skills and demonstrate understanding of related medical device and/or electronic component manufacturing operations.
• The ability to handle multiple projects at the same time while being able to keep each project on track and communicate issues with concise and actionable input is essential.
• Familiarity with material considerations of medical device products.

EXTRA AWESOME:

• Knowledge of federal and other regulations, especially as related to medical device design and manufacturing, e.g., QSRs, ISO 14971 IEC 60601 series is desirable.
• Knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) is desirable.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $81,620 - $102,0870 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.

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.

#LI-Hybrid #LI-KL1