Senior Bioinformatician (Validation Specialist)

Conteúdo do emprego

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 Rolleand 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.

• Collaborate on the verification of the product design and drive the analytical and clinical validation activities, including the creation of validation plans, protocols and reports.
• Analyse product requirements, user risks (FMEAs) and system requirements
• Create work estimates for design validation tasks to support planning activities
• Develop, coordinate and implement analytical and clinical validation studies for in vitrodiagnostic devices in cooperation with cross-functional teams
• Analyse the validation data and report the results to multidisciplinary teams
• 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)

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.