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Software QA Engineer

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29/02/2024 100% Permanent position
Tandem Diabetes Care Switzerland Sàrl

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.

Software QA Engineer

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 will work independently to 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. They will be responsible for documenting all software and firmware of the company, in compliance within established standard operating procedures of our quality management system.

  • Sets 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.
  • Develops software standard operating procedures, software test methodologies, and software verification & validation protocols and reports.
  • Writes all software specifications.
  • Drives risk management activities (hazard identification, risk assessment and risk control) for all software development and participate to overall project risk management activities with team.
  • Advises and support engineers on regulatory compliance for Software and General Data Protection Regulation.
  • Leads computer software validation used for the monitoring and measurement of requirements and used in the Quality Management System (AAMI TIR 36)
  • Collaborates with team members to determine best practices and requirements for software.
  • Develops product specifications with attention to system integration and feasibility.
  • Coordinates and oversee technical standards in collaboration with QA/RA team, including software coding standards, tools, and platforms.
  • Ensures effective change control activities during the product life cycle.
  • Creates the required documentation (design history file) for each software release.
  • Creates and supports test protocols for the verification and validation of hardware and embedded software.
  • Partners closely with other team members to successfully bring the prototypes in clinical study and obtain regulatory approvals.
  • Independently manages third-party vendors including software components providers.
  • Confirms completion of required training plan before assuming job responsibilities.
  • Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
  • Other responsibilities as assigned.

YOU’RE AWESOME AT:

1. Knowledge, skills & abilities:

  • 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.

2. Minimum certifications/educational level:

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

3. Minimum 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

Contact

Déborah Lavabre


About the company
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