The Wyss Center is an independent, non-profit research and development organization that advances our understanding of the brain to realize therapies and improve lives. The Wyss Center staff, together with the Center’s academic, clinical and industrial collaborators, pursue innovations and new approaches in neurobiology, neuroimaging and neurotechnology.
The Wyss Center advances reveal unique insights into the mechanisms underlying the dynamics of the brain and the treatment of disease to accelerate the development of devices and therapies for unmet medical needs. The Center was established by a generous donation from the Swiss entrepreneur and philanthropist Hansjörg Wyss in 2014. Additional resources from funding agencies and other sources help the Wyss Center accelerate its mission.
The Quality Assurance (QA) Engineer will work both independently and collaboratively at the Wyss Center to facilitate the development of advanced implantable neurosensing and neuromodulation devices that are designed to collect real-time neural signals, to transmit multichannel recordings and to provide closed loop control signals for a range of applications. More specifically, the individual will work to support and maintain Quality Assurance processes and support multiple projects, as part of the Wyss Center’s mission to develop and translate to the market innovative medical devices and therapies.
The ideal candidate will be a key player in the Wyss Center team, implementing compliant Quality Assurance processes according to which these medical systems (Class III medical systems consisting of implantable and external medical device components and Software As Medical Devices) are designed and developed, validated and brought to market.
He/she will report directly to the Center’s QA Manager.
In his/her position, the Quality Assurance (QA) Engineer will mainly:
- Be responsible for quality assurance activities to support and maintain the Quality Management System.
- Act as Quality Assurance Project leader for some of the Wyss Center projects, including support for design reviews.
- Support projects and Quality Management System related nonconformities and Corrective and Preventive Actions (CAPAs).
- Ensure effective design change control activities during the product life cycle.
- Conduct and support key supplier’s audits
The candidate should be flexible and open to providing quality solutions for neurotechnology applications in a cutting edge, multidisciplinary environment, with an appetite for software. The candidate must also be able to work independently and propose innovative approaches to quality paths.
Required competence and experience:
- MS in Engineering or relevant Life Science discipline, with 3 years of experience in a similar position in the medical device industry.
- Knowledge of the of the MDR 2017/745/EU, the FDA 21 CFR Part 820 and ISO 13485 requirements.
- Experience with maintenance of Quality Management Systems and Processes for Medical Devices.
- Exposure to IEC 62304 Software Lifecycle process standard requirements would be a plus.
- Comfortable working autonomously but also a team player.
- Strong at taking initiative, fast learner, enthusiastic, curious.
- Very high attention to detail.
- Fluent in English; proficiency in French a plus.
- Experience or interest in neuroscience
- Experience with Jira and Bitbucket a plus
To apply, please send your CV and cover letter to HR@wysscenter.ch no later than 1st May 2022
Le Campus Biotech à Genève est un centre d’excellence pour la recherche en neurosciences hébergeant des laboratoires de l’Ecole Polytechnique Fédérale de Lausanne (EPFL) et de l’université de Genève. Ces derniers effectuent des recherches fondamentales et appliquées de haut niveau en neurosciences cognitives, affectives, cliniques ou psychiatriques.
Are you a Senior Developer with the below requested experience in full stack web development looking for a position where you can have an impact on the life of patients? A part of participating in providing tools to improve clinical interpretation, are you looking for a dynamic and flexible working environment? Then, this position is for you.
About the Wyss Center for Bio and Neuroengineering
The Wyss Center is an independent, non-profit research and development organization that advances our understanding of the brain to realize therapies and improve lives.
The Campus Biotech in Geneva houses neuroscience laboratories from the Swiss Federal Institute of Technology of Lausanne (EPFL) and the University of Geneva.