Sr Systems Engineer I (Design Process and Quality Initiatives)

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: 

Hybrid: This role will be a mix of in-office work at our corporate headquarters in Del Mar, CA and remote work. This position is expected to be in office 3 days per week, but may vary depending on business needs. 

A DAY IN THE LIFE:

Join our team as a Sr Systems Engineer I (Design Process and Quality Initiatives) and play a key role in shaping the future of our innovative pump technology. You'll work cross-functionally to enhance the definition, design, and development of Tandem’s products.

This position will focus on driving design and development processes by working with cross-functional teams as part of requirements management software roadmap. The position will drive the best practices to support all portfolio projects and enable broader user adoption. The position will also lead quality initiatives such as configuration management and design process CAPAs.

• Drives process framework, process logistics and tool instrumentation to support requirement management software roadmap.
• Partners and collaborates with the senior leadership within Systems engineering team and quality team to drive quality initiatives such as configuration management and design process CAPAs.
• Contributes to the development and maintenance of inter-system interface specifications and contracts, considering cross-subsystem impacts.
• Contributes to the risk management process and derives risk mitigation requirements.
• Provides system expertise to support on-market-products technical support troubleshooting, failure analysis, and triage of system level issues.
• Maintains tight collaboration with the teams responsible for product V&V, writes and reviews test plans and protocols, and helps triage issues uncovered during testing activities.
• Works closely with the SW and HW development teams to flow down the system and subsystem requirements and assist with establishing traceability.
• Serves as a key member of a cross-functional project team consisting of product managers, test/quality engineers, development engineers, manufacturing, and other stakeholders.
• Identifies and documents system interdependencies to mitigate hazards, failure modes, and other risks.
• Supports other departments as needed and considers project-wide impacts in decision making.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Mentors more junior system engineers in the performance of their duties.

WHAT YOU'LL NEED:

• Knowledge, skills & abilities:
  • Demonstrated ability to champion and instrument process initiatives (requirement, risk and test management) with a tool such as Jama or equivalent .
  • Demonstrated capability in quality initiatives and supporting design and development CAPAs.
  • Ability to dive into the details and analyze different cross functional inputs to produce suitable solutions.
  • Ability to work independently and deliver a high-quality work product without close supervision.
  • Ability to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
  • Ability to effectively convey information related to work product and lead group discussions.
  • Familiarity with one or more of the following: ISO 13845, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls, HIPAA and/or GDPR, preferred.
• Minimum certifications/educational level:
  • Bachelor of Science or equivalent degree in System Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomed