Test Team Lead

vor 2 Wochen

SaintSulpice, Schweiz Tandem Diabetes Care, Inc. Vollzeit

**GROW WITH US**:
AMF Medical, 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**

AMF Medical 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**:
Working from AMF Medical’s office onsite in Switzerland, you’ll be a key player for Sigi design verification, ahead of clinical trials and regulatory submissions. These tests, carried out according to ISO 13485 requirements, will demonstrate functionality, efficiency and sufficient reliability of the Sigi system to build the technical file of the product, as necessary to submit requests to ethical committees and health authorities before beginning clinical tests and to build a technical file for preparing submission to regulatory authorities. The Test Team Leader directs and oversees the Verification & Test team in developing and releasing outstanding test strategies for Sigi. Drives a culture of developing high quality test benches. They will also be responsible for the maintenance of the laboratory equipment, as well as the calibration of all test equipment.
- Manages and leads the Verification & Test team - hiring, training, coaching, and mentoring.
- Builds and scales the Verification & Test team in skills and size commensurate to the scope and complexity of our products.
- Plans, distributes and follows testing activities including requirements, design, development, and test
- Works with Director, QA and Regulatory Affairs to develop a technical roadmap, strategic objectives, and plans for clear deliverables.
- Liaises with the broader Tandem test teams.
- Collaborates closely with Product Engineering and QA/RA teams to develop an outstanding test strategy.
- Works with Product Engineering to ensure that tests and bench tests are aligned with actual product use scenarios and conditions.
- Establishes a test strategy towards establishing test protocols.
- Oversees the running of pre-tests and verification tests.
- Leads the design verification tests under ISO 13485.
- Identifies gaps in existing test benches, including mechanics, electronics and software and define requirements for the (internal or external) realization of new test benches.
- Designs and build test benches.
- Identifies, briefs and manages external partnerships and resources related to test bench realization.
- Oversees calibration and maintenance of laboratory equipment.
- Ensures department staff is properly trained, per designated training plan, before assuming job responsibilities.
- Develops and manages schedules and performance requirements of staff.
- Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
- Other responsibilities as assigned.

**YOU’RE AWESOME AT**:

- Extensive experience in mechanical or electronics testing (tensile tests, fatigue, accelerated aging, reliability, etc.).
- Experience with measurement systems.
- Demonstrated experience in team management.
- Experience in calibration of measuring or testing equipment (traction/compression testing machine, oscilloscopes, ovens, precision balances, micrometers, electro-mechanical test benches, etc.)
- Strong knowledge of ISO 13485 environment
- Knowledge in electronics and software is a plus.
- Experience with IEC 60601 is a plus.
- Demonstrated ability to work within a fast-paced start-up environment in a small team setting.
- Mastery of MS-Office tools.
- Experience coordinating activities with outside test labs or reliability consultants to ensure the delivery of services needed to meet scheduled timelines.
- Good oral and written communication skills with the ability to champion own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information as well as accepting and implementing ideas of others.
- Skilled at promoting team cooperation and a commitment to team success.
- Fluent in French and English (C1 proficiency).

**EXTRA AWESOME**:

- Master’s degree in microtechnology, mechanics, electronics or other related field or equivalent combination of education and applicable job experience.
- 5 years’ experience in a medical device testing environment.

**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 r

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