Je bent hier: Vacatures / Senior Usability Engineer @ Salvia BioElectronics
ABOUT US
Salvia BioElectronics is a medical device company pioneering neuromodulation therapies for migraine. Salvia's unique, paper-thin
implant is designed to reduce the frequency and intensity of migraine attacks by delivering gentle electrical pulses to the nerves
associated with the condition. The company is currently in the clinical stage of development. In addition, Salvia is considering
potential opportunities the device creates for the treatment of cluster headache and other neurological disorders. Salvia has
received the Breakthrough Device Designation from the United States Food and Drug Administration (FDA), which facilitates
expedited market access for devices that treat life-threatening or irreversibly debilitating conditions.
THE CHALLENGE
We offer a challenging position for a Senior Usability Engineer who will shape, own and drive our human factors/usability
engineering program. As a Senior Usability Engineer, you set up and maintain the usability engineering file and you take ownership
of closing the loop from feedback from the field to the development team. You enjoy working at the heart of a multi-disciplinary
and dynamic scale-up environment. Most importantly, you bring a can-do attitude, you have a sharp eye for quality and you
partner up with the team to ensure timely realization of human factor deliverables as required for regulatory submissions.
RESPONSIBILITIES
• Coordinating and conducting human factors/usability engineering, in close collaboration with the product management,
quality, regulatory and clinical team.
• Ongoing development of the use analysis in collaboration with our risk management team.
• Bolster continuous product improvement by providing feedback to product management and development (e.g. UX,
functionality, complaints handling), as a key contribution to delivering outstanding products.
YOUR PROFILE
• MSc degree in a relevant engineering discipline.
• Working experience in a medical device Quality Management System (ISO 13485).
• On-the-job experience in human factors/usability engineering (IEC 62366).
• Affinity with risk management. (ISO 14971).
• Proven track record in creating the usability engineering file for medical device products, preferably active implantable
medical devices.
• Results oriented, hands-on attitude.
