Sr. Compliance 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 a “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 t:slim X2 insulin pump with Control-IQ technology. We’re also 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. Since 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 tandemdiabetes.com.

A DAY IN THE LIFE:

A senior team member contributing to the development, documentation, and testing of the Company’s medical devices and systems to ensure compliance with recognized standards, including but not limited to IEC 60601-1. Works with mechanical, electrical and software engineers determine requirements for compliance with appropriate standards and takes an active role in the verification of compliance.

• Provides design inputs and authors requirements to ensure product compliance with recognized standards such as the IEC 60601-1 series.
• Communicates with outside test labs and internal groups to coordinate schedules for performing IEC 60601-1 compliance testing in order to meet project schedules.
• Produces test plans, test protocols, and test reports for IEC 60601-1 compliance testing. This includes working with the development team to identify appropriate test configurations and acceptance criteria.
• Works with outside test labs to ensure that compliance testing is performed correctly and that reports are accurate and released in a timely manner.
• Works with test engineers and technicians during compliance testing to ensure that they are properly trained and understand the test plan.
• Works with development engineers to identify fixtures and equipment necessary for compliance testing and identify design requirements when new fixtures or equipment is required.
• Performs troubleshooting and issue resolution during compliance testing to determine if there are design deficiencies.
• Executes formal Change Orders within Tandem’s quality system workstream.
• Works with the quality and development teams to create compliance checklists.
• Works with the quality team to identify risks and required mitigations for standards compliance.
• Performs gap assessments between standards editions and how changes to standards impact product design, testing, and documentation.
• Embraces the Design Control process by participating in design reviews.
• Confirms completion of required training plan before assuming job responsibilities.
• Supports other departments as needed and considers project-wide impacts in decision making.
• Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.

YOU’RE AWESOME AT:

• Comfortable working with software/firmware centric products with imbedded software.
• Able to learn product software upgrades via wireless means.
• Has knowledge of federal and other regulations, especially as related to medical device design and manufacturing, e.g., QSRs, ISO 14971, and IEC 60601 series.
• Knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
• Able to work independently and deliver high quality work product without close supervision.
• Able to respectfully assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
• Able to effectively convey information related to work product and lead group discussions; demonstrated ability to lead work teams.
• Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.

EXTRA AWESOME:

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related field or equivalent combination of education and applicable job experience.
• Advanced coursework, Master’s degree, or professional licensing in related field desirable.
• 5+ years of relevant industry experience.
• 3+ years of experience in IEC 60601-1 medical device compliance testing or equivalent.

WHAT’S IN IT FOR YOU?

In addition to innovative technology, we have a culture that fosters the idea