- Meticulously execute test protocols, including conducting precise pre-tests.
- Perform prototype verification tests in compliance with ISO 13485 regulations.
- Thoroughly document test results and prepare comprehensive test reports.
- Precisely document and analyze test failures, capturing key information for further analysis.
- Participate in the development of test methods.
- Contribute to the calibration and maintenance of laboratory equipment to uphold standards of accuracy.
- Maintain strict compliance with company policies, including GDPR/HIPAA and other regulatory, legal, and safety requirements.
- Other duties as assigned.
- Proficiency in reading and following procedures and flow diagrams with acute attention to detail.
- Effective communication skills, both written and verbal, with the ability to articulate issues and recommendations clearly and concisely.
- Hands-on experience with measurement systems and instrumentation.
- Additional experience working in a medical device test lab, including experience designing, documenting, and performing test procedures is a plus.
- Demonstrated proficiency in writing test reports, protocols, and work instructions.
- Experience working within an ISO 13485 environment, ensuring strict adherence to quality standards.
- Knowledge of MSA methodology/test method validation and statistical techniques a plus
- Mastery of MS-Office tools for documentation and reporting purposes.
- Proven ability to prioritize tasks effectively, manage multiple responsibilities, and complete assignments with precision and minimal errors.
- Fluency in French, with advanced proficiency in written English for reading test protocols and composing test reports.
- Experience with IEC 60601 standards would be advantageous.
- Diploma of technician, Swiss CFC or equivalent qualification in microtechnology, mechanics, electronics or related fields.
- 2 years' professional experience, preferable in test laboratory environment.
- Solid experience in mechanical or electronics testing (tensile tests, fatigue, accelerated aging, reliability, etc.)
- 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
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Test Technician - St-Sulpice VD, Schweiz - Tandem Diabetes Care Switzerland Sàrl
Gefunden in: Jobsch CH C2 - vor 3 Tagen
Beschreibung
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 SigiTM, 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 Test Technician will play a pivotal role in the verification process for the SigiTM Insulin management system, ensuring adherence to ISO 13485 standards. This position is integral to validating the functionality, efficiency, and reliability of the SigiTM system in preparation for clinical trials and regulatory submissions.
Working from Tandem Diabetes Care Switzerland's office onsite in Switzerland, you'll....
YOU'RE AWESOME AT:
YOU'LL NEED:
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:
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.
REFERRALS:
We love a good referral If you know someone that would be a great fit for this position, please share