Alle rechten voorbehouden 2024
The human body is controlled by patterns of electrical impulses transmitted through nerve fibers. In chronic disease, these patterns are different. Bioelectronics are tiny implantable devices that use mild electrical pulses to influence nerve activity. Electrical stimulation is nothing new – cardiac pacemakers have been used for decades – but scientists are just beginning to realize the possibilities of regulating nerve signals to treat disease.
Our client is an innovative and ambitious start-up company active in the emerging field of “BioElectronics” that is inspired by biology and electronics to provide novel therapeutic solutions. They are driven to deliver bioelectronic solutions that restore health for people suffering from severe neurologic disorders (cluster headache and migraine) and the ambition is to make these therapies widely accessible.
The Salvia team consists of entrepreneurs, engineers and scientists with diverse professional backgrounds and extensive medical device industry experience (Sapiens, Medtronic, Philips, St Jude, etc.). Salvia is headquartered in Eindhoven (HTC).
The challenge
Are you interested in testing a highly innovative medical device system to ensure it meets requirements and understand the system’s failure mechanisms? At Salvia you have the opportunity to contribute to an extensive test program for a medical neurostimulation system, consisting of implantable and wearable devices. Objectively demonstrating safety and performance is the core of your job. You help unravel failure mechanisms and investigate the limits of the system. You ensure compliance to relevant product standards and verification test methods covering the novel technical aspects of the Salvia product. You document objective evidence in order to meet the needs of the FDA and the EU Medical Device Regulation. You will be part of our multidisciplinary development team and collaborate with our engineers to demonstrate the technical performance of our solution and identify areas for improvement. While maintaining a big-picture overview and oversee multiple technical disciplines, you dive into details and work hands-on. You realize that quality is of paramount importance and you are passionate about delivering solutions that perform, are safe, and comply with all relevant standards.
Your key responsibilities are:
· Establish objective evidence of safety and performance of Salvia’s bioelectronic system:
o Analyze failure modes
o Define verification protocols
o Validate test methods and contribute to the development of inhouse test setups
o Test products and components and interface with the design engineers to resolve problems
o Interface to external test-houses to ensure products comply to relevant standards
· Collaborate with QA, RA to release the Salvia products to the market
Your profile
· MSc or BSc degree in the engineering field
· Minimum of 5 years of industry experience in a similar testing role in a regulated industry, e.g. medical, automotive or aerospace
· Self-starter, naturally taking ownership
· Critical thinker, structured and strong analytical skills
· Strong communicator; team player; solution-oriented
· Experience with statistical techniques is a benefit
What our client offers
Salvia aims to empower people to advance innovative technologies, develop meaningful solutions, and build rewarding careers. This includes:
· A competitive salary
· 8% holiday allowance
· 25 holidays (with the option to add 5 more days per annum)
Interested in joining?
If you are interested in this unique position or simply want more information, please reach out to Reinoud Olivers of High Tech Source. Contact details: reinoudolivers@hightechsource.nl and +31 6 14 52 73 72