Would you like to be part of a dynamic and exciting Data Science organization that uses cutting edge technologies to deliver a world changing product that has a direct impact on the lives of cancer and rare disease patients worldwide? Join our Genomic Research team in Lausanne and Rolle and use your exceptional technical skills to help us deliver on our mission of democratizing Data-Driven Medicine. Our products are used by thousands of healthcare institutions globally and provide world leading capabilities for the analysis of genomic, clinical, and imaging data.
We are seeking an enthusiastic, proactive and organized individual to join our research and development team, able to adapt to our continually evolving environment.
You will:
- Collaborate and support for the verification of the product design as well as clinical validation activities, including the creation of validation plans, protocols and reports.
- Analyse product requirements, user risks (FMEAs) and system requirements
- Develop, coordinate and implement clinical validation studies for medical devices.
- Analyse of the data and reporting of the results to multidisciplinary teams
- Cooperate with cross-functional teams to carry out validation studies
- Create work estimates for design validation tasks to support planning activities
- Create and maintain the traceability of user requirements, user risks and validation protocols
Requirements
- PhD and/or several years postdoc or industry experience in bioinformatics and NGS data analysis
- 3 to 6 years of professional experience in product development or quality assurance, preferably in companies for medical devices or IVDR
- Familiarity with working under ISO 13485: 2016/21 CFR 820. Experience in the implementation of the requirements according to ISO: 13485 / IVDR / FDA 21 CFR 820 including software is a plus.
- Familiarity and experience with the requirements for medical device / IVDR standards, including product verification / validation, design control, usability engineering, product life cycle processes
- Able to function in cross-functional teams, aligning and rallying the different stakeholders with professionalism and clarity.
- Professional English speaking and writing skills.
Benefits
- Career opportunities in a fast-growing company with worldwide reputation
- A flexible and friendly working environment with a collaborative atmosphere
- Fantastic office locations in Switzerland
- An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illness.
- A fast-growing company with plenty of opportunity for personal growth and development
Start: ASAP (or as agreed)
Contract type: permanent full-time
Location: Office based, Lausanne or Rolle (Switzerland)
Application process:
If you think you fit this position, please send a CV and a cover letter. Please note that incomplete applications will not be considered.
After an initial screening process, candidates will be invited for remote interviews. Selected candidates will then be invited for personal interviews.