Test Team Leader

vor 1 Woche

Ecublens, Schweiz Swiss ELS Vollzeit

_The Test Team Leader will 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._

**Primary Duties and Responsibilities**
- Manage and lead the Verification & Test team - hiring, training, coaching, and mentoring
- Build and scale the Verification & Test team in skills and size commensurate to the scope and complexity of our products
- Plan, distribute and follow testing activities including requirements, design, development, and test
- Work with Director, QA and Regulatory Affairs to develop a technical roadmap, strategic objectives, and plans for clear deliverables
- Liaise with the test team of Tandem Diabetes Care
- Collaborate closely with Product Engineering and QA/RA teams to develop an outstanding test strategy
- Work with Product Engineering to ensure that tests and bench tests are aligned with actual product use scenarios and conditions.
- Establish a test strategy towards establishing test protocols
- Oversee the running of pre-tests and verification tests
- Lead the design verification tests under ISO 13485
- Identify gaps in existing test benches, including mechanics, electronics and software and define requirements for the (internal or external) realization of new test benches
- Design and build test benches
- Identify, brief and manage external partnerships and resources related to test bench realization
- Oversee calibration and maintenance of laboratory equipment
- The employee may be required to perform other tasks for the smooth running of the company

**Key Skills and Temperament**
- Passionate about test strategy development, autonomous and proactive
- Hands-on, with a high interest in designing and building test benches
- Committed to finding the most appropriate tests to adequately characterize Sigi system and methods to performing these tests - for patient safety. Interested in measurement techniques and their implementation
- Meticulous, rigorous, systematic and reliable
- Autonomous, organized and able to handle challenging milestones
- Great team player with a collaborative mindset toward other teams
- Committed to finding the best technical solutions

**Education, Training and Experience**
- Master degree or equivalent in microtechnology, mechanics, electronics or other related domain
- 5 years+ experience in medical device testing environment
- 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,...)
- Strong knowledge of ISO 13485 environment
- Fluent in French and English (C1 proficiency)
- 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

**Organizational Relationships**
- Reports to the Director, QA & Regulatory Affairs.

**We Offer**
- A high-tech and innovative environment in Medtech, part of a leading global diabetes technology company
- Excellent working conditions, autonomy, being part of a motivated and highly qualified team
- Very interesting and stimulating work in an innovative field with high potential
- A pleasant environment within the EPFL Innovation Park, with possibility to benefit from the campus infrastructure

Type d'emploi : Temps plein

Programmation:

- Travail en journée

Lieu du poste : Un seul lieu de travail

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