GROW WITH US:

Tandem Diabetes Care Switzerland Sàrl, a subsidiary of Tandem Diabetes Care, Inc., is a MedTech start-up located in EPFL’s Innovation Park in Lausanne, Switzerland. Tandem Diabetes Care, Inc., is a global insulin delivery and diabetes technology company based in San Diego, California. Together we are creating new possibilities for people living with diabetes, their loved ones, and the healthcare providers through a positively different experience.

INNOVATE EVERYDAY:

Tandem Diabetes Care Switzerland is developing Sigi™, a next-generation insulin “patch pump” that will offer additional treatment options for people with diabetes. This pump is based on a patented microfluidics technology developed in-house over the past 6 years. You can find out more about Sigi here .

A DAY IN THE LIFE:

The Software Quality Assurance Engineer is responsible for providing quality guidance and support for software product launch, sustaining engineering software projects, and quality system activities to assure conformance to established specifications.
Please note that this role will not be responsible for any software development or testing, but rather guiding our software teams in quality assurance, risk management, and compliance activities to ensure the successful launch and sustainability of software products, while optimizing internal operations for efficiency and quality.

Working from Tandem Diabetes Care Switzerland’s office onsite in Switzerland, you’ll….

• Set up all the tools and procedures required to develop the firmware and software of our insulin injection system in compliance with IEC 62304 and ISO 13485.
• Develop software standard operating procedures, software test methodologies, and software verification & validation protocols and reports.
• Write all software specifications.
• Drive risk management activities (hazard identification, risk assessment and risk control) for all software development and participate to overall project risk management activities with team.
• Advise and support engineers on regulatory compliance for Software and General Data Protection Regulation.
• Lead computer software validation used for the monitoring and measurement of requirements and used in the Quality Management System (AAMI TIR 36)
• Collaborate with team members to determine best practices and requirements for software.
• Develop product specifications with attention to system integration and feasibility.
• Coordinate and oversee technical standards in collaboration with QA/RA team, including software coding standards, tools, and platforms.
• Ensure effective change control activities during the product life cycle.
• Create the required documentation (design history file) for each software release.
• Create and support test protocols for the verification and validation of hardware and embedded software.
• Partner closely with other team members to successfully bring the prototypes in clinical study and obtain regulatory approvals.
• Independently manage third-party vendors including software components providers.
• Confirm completion of required training plan before assuming job responsibilities.
• Ensure work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.

YOU’RE AWESOME AT:

• Outstanding knowledge of IEC 62304. Shall have already implemented the necessary process and tools to develop firmware and software according to this standard.
• Experience with FDA software validation, Cybersecurity, Data Protection and Artificial Intelligence guidance.
• Deep knowledge of software engineering, both process and tools (incl. continuous integration and testing).
• Experience performing software risk management for Class IIa (or higher) medical devices.
• Solid experience in structured product development (requirements-driven engineering, architecture modeling, detailed design, SW FMEA, formal verification, release processes, etc.).
• Experience with development within an ISO 13485 certified QMS.
• Demonstrated ability to work within a fast-paced start-up environment in a small team setting.
• Comfortable working autonomously and also as a team player.
• Experience and/or specialization in one or more of the following areas:
  • Health software – IEC 82304-1
  • Standards for Cybersecurity – UL 2900-1, IEC 62443 series, FDA guidances
  • Guidances on Software as a Medical Device
  • Experience in the application of ISO 14971 to medical device software and link with IEC 62304
  • Artificial Intelligence is a plus
  • Experience in C and C++ language
  • Medical electrical equipment – IEC 60601 series
  • General Data Protection Regulation (EU) 2016/679
• Excellent written and verbal communication skills.
• Ability to effectively use MS Office suite (Word, Excel, Outlook) and other applicable software packages.
• Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
• Fluent in French, excellent in English.

YOU'LL NEED:

• Bachelor’s degree in Software Engineering, Computer Sciences or related field or equivalent combination of education and years of applicable experience.
• 3 years’ professional experience.

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. We offer:

• A high-tech and innovative environment in MedTech
• Excellent working conditions, autonomy, being part of a motivated and highly qualified team
• Interesting and stimulating work in an innovative field with high potential
• Pleasant environment within the EPFL Innovation Park, with possibility to benefit from the campus infrastructure

BE YOU, WITH US!

We are 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.