2 Medical technology emplois à Pully trouvés

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.

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 Test Engineer will play a pivotal role in the verification process for the Sigi™ Insulin management system, ensuring adherence to ISO 13485 standards. This position is integral to validating the functionality, efficiency, and reliability of the Sigi™ system in preparation for clinical trials and regulatory submissions.

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

• Develop and execute hardware test plans, test cases, and test scripts for various components.
• Identify defects and report them to the development team for resolution.
• Commission and debug new test equipment.
• Manage equipment validation processes.
• Develop and maintain automated test suites for hardware products.
• Develop and maintain test fixtures and test equipment.
• Work in collaboration with ME, EE, SW, and FW teams to ensure seamless integration with new prototype hardware.
• Work with Technicians to build prototypes, install new systems, and execute tests on existing test stations.
• Perform Root Cause Analysis on equipment and test article failures.
• Document test reports and maintain records.
• Maintain strict compliance with company policies, including GDPR/HIPAA and other regulatory, legal, and safety requirements.

YOU'RE AWESOME AT:

• Committed to finding the most appropriate tests and test methods.
• Meticulous, rigorous, systematic and reliable.
• Comfortable working autonomously and also as a team player.
• Fluency in English (written and spoken) required, fluency in French (spoken) strongly preferred.
• 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.
• Experience with IEC 60601 standards would be advantageous.

YOU'LL NEED:

• Master’s degree in Microengineering, Electronics or relevant field, or equivalent combination of education and years of applicable experience.
• 2 years’ experience in the field of medical device testing or in a related area.
• Experience with a multitude of laboratory test equipment.
• Knowledge of automated testing tools and frameworks.
• Demonstrated experience in writing test protocols and reports.
• Solid experience in mechanical or electronics testing (tensile tests, fatigue, accelerated aging, reliability, etc.)
• Experience in Computer System Validation is a plus.
• Experience in reliability engineering is a plus.
• Experience in microfluidic testing is a plus.
• Experience working in an ISO 13485 environment is a plus.

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!