VP, Systems Test & Development Quality
Job description
GROW WITH US:
“In Tandem” means together, and we strive to embody that in every aspect of our business. Whether your office-based or fully remote, Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and the healthcare providers supporting them through a positively different experience.
INNOVATE EVERYDAY
At Tandem, we strive to put our values into action. Our “Team Up”, “No shortcuts” approach has propelled us to be an industry leader and make significant strides in the diabetes technology space. We are proud to be the makers of the only color, touch-screen insulin pump that is capable of remote feature updates and compatibility with continuous glucose monitoring. Watch our latest video to see our product features and capabilities here: t:slim X2™ Insulin Pump with Control-IQ™ Technology
A DAY IN THE LIFE:
The Vice President, System Test is responsible for leading the design, development and system test engineering strategies for Tandem’s innovative hardware, software, Digital Health products and related services. Demonstrating leadership of a large team of Test Engineers, Automation Engineers, and Design Quality Engineers to partner with R&D, IT, PMO and other cross functional teams to ensure Tandem products are designed, developed, and transferred in accordance with company policies and procedures governing Design Control, System Test Engineering, Automation, and pre-market Risk Management activities.
The VP, System Test role is also responsible for building a vision for design quality and system test engineering, communicating, and driving that vision across functional teams. This role is accountable for establishing testing framework that defines, implement and measures testing controls and standards across the organization. Developing a clear strategy and a roadmap for implementing structured system testing methodologies for Functional, Integration, Regression, End-to-End and Performance testing (Load, Stress, Spike, Endurance) for all product projects is critical to role and company success.
Reporting directly to the Senior Vice President Regulatory Affairs & Quality and leading in developing overarching System Test and design & development plans, the VP, System Test, is well-connected to Tandem’s leadership team and is focused on enabling new product introductions and establishing and maintaining governance processes across Enterprise
YOU’RE AWESOME AT:
PRIMARY DUTIES & RESPONSIBILITIES:
- Providing direction to design quality and system test engineering leaders to define and build testing frameworks, system test strategy and related processes to build quality into every step of the development process.
- Collaborating with R&D, PMO, IT, Product Management, and other cross functional leaders to provide definition and direction to overall engineering process requirements, design specifications and SRS; ensuring all requirements are actionable, measurable, and testable.
- Demonstrating full accountability for defining Test Management Infrastructure (people, process, technology) to facilitate and support all testing efforts throughout the product life cycle, including developing technical plans for all projects to test early, test strategically, test continuously and test visibly.
- Implementing validated test management tools to centralize and link all testing artifacts including requirements, test case, test beds, test scripts, test execution and defects for all projects.
- Developing testing dashboards on all projects and providing testing updates and progress to all cross-functional team on bi-weekly basis.
- Developing and implementing test strategies and test design techniques for ad-hoc, walkabout, regression, functional, system integration, backend and end-to-end testing.
- Building capacity and capability within the test team for Performance testing (Load, Stress, Spike, Endurance) to test the system to its designed operational level and observe the breakpoint of the system or point of performance degradation.
- Leading a team of design quality engineers to support all design control activities for change development process and product development process.
- Building design quality and reliability plans for new and sustaining product development projects and partnering with R&D to drive an effective pre-market reliability throughout product development lifecycle; partnering with post-market reliability team and leverage existing expertise tools and processes.
- Defining and maintaining a comprehensive pre-market Risk Management Program for all products as per ISO 14971, including leading teams in risk evaluation techniques, e.g. SFMEA, DFMEA, PFMEA & fault tree analysis and building software specific FMEA’s for digital health products and risk management report.
- Partnering with Post-Market Risk Management team to complete Health Hazard Assessment and Risk Assessments.
- Significant knowledge of software development life cycle processes (waterfall/agile/DevOps) as applied within the regulated medical device industry.
- Exposure to medical device compliance standards (such as ISO13485/IEC62304/HIPAA /FDA/Security Standards/Data Privacy).
- Experience in design controls, formal V&V, DRM, critical-to-quality strategies, risk management and cybersecurity.
- Experience and knowledge of mechanical and electrical engineering product development lifecycle.
- Demonstrated knowledge in software development lifecycle, including familiarity with embedded software and firmware, applications software and analytics; knowledge of software quality for mobile device apps and remote installation is a plus.
- Experience supporting internal/external regulatory audits is a plus.
- Excellent analytical, technical, and problem-solving skills.
- Experience in driving succession planning at all levels.
Minimum certifications/educational level:
- Bachelor’s degree in a technical field (Math, Statistics, Engineering, or related scientific discipline).
- Advanced degree in related field, preferred.
Minimum experience:
- Twelve plus years of system test engineering experience in testing software, firmware, hardware, and integrated systems as a whole.
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.
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-for-job-applicants
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