Biomedical Engineer

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 Biomedical Engineer will be responsible for developing and running insulin compatibility, biocompatibility, leachables and extractables testing and sterilization routine and validation activities for Sigi Insulin management system.

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

• Support vendor relationships and testing with outsourced laboratories for insulin compatibility, biocompatibility and sterility insurance by reviewing quotes, placing orders for testing, preparing and shipping samples, coordinating the teams.
• Compile and manage test results and write reports that will be used to support regulatory submissions for our products.
• Write detailed and easily understood work instructions, test protocols, and test reports.
• Review test protocols and specifications to verify system performance. Document test verification in reports with supporting data.
• Participate in formulation of hypotheses, design experiments, and conduct testing to inform decision-making.
• Participate in test planning and scheduling.
• Maintain, conduct and improve routine microbiology monitoring (product and production environment).
• Contribute to development of sterilization validation and ensure that validation is performed in compliance with the requirements.
• Support Tandem team in scientific writing, literature review and data analysis
• Execute test protocols for Insulin Compatibility testing that includes test setup, programming profiles for pumping, sample preparation and sample collection.
• Participate in defining requirements of mechanical systems, experimental designs and specialized test equipment associated with insulin compatibility testing.
• Confirm completion of required training plan before assuming job responsibilities.
• Follow safe practices when handling hazards (biological and chemical) and adhere to proper disposal practices.
• Ensure compliance with company policies, including GDPR / HIPAA, and other legal and regulatory requirements.
• Other duties as assigned

YOU’RE AWESOME AT :

• Ability to communicate technical knowledge to varying levels within organization and with outsourced laboratories.
• Some knowledge of Good Documentation Practices (GDP).
• Exposure to testing methodology in a product development environment.
• Ability to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
• Excellent written communication skills.
• Capable of using statistical techniques and tools to summarize data and support conclusions.
• Ability to work effectively in a team environment at all levels within the organization.
• Ability to alter behavior and opinions in light of new information.
• Experience with MS Office.
• Fluency in English (written and spoken) required, fluency in French (spoken) strongly preferred.

YOU'LL NEED :

• Bachelor’s degree in Biomedical Engineering, Biology, Chemistry or related field, or equivalent combination of education and experience.
• 6 months of experience in a lab setting including detailed development of test methods and protocols and writing detailed reports.

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
Il y a 19 jours