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... more details
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 that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit https://www.tandemdiabetes.com/careers.
BE YOU, WITH US!
Tandem is 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 $106,000 - $130,000 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, 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 (starting in year 1) and have access to a 401k plan with company match. Learn more about Tandem’s benefits here!
YOU SHOULD KNOW:
Potential new employees must successfully complete a drug screen (excludes marijuana) and background check which includes criminal search, education certification and employment verification prior to hire.
REFERRALS:
We love a good referral! If you know someone that would be a great fit for this position, please share!
If you are applying for this job and live in California, please read Tandem’s CCPA Notice: https://www.tandemdiabetes.com/careers/california-consumer-privacy-act-notice-f or-job-applicants.
#LI-KT1 #LI-Hybrid
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.
The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.
