We offer the opportunity to contribute to our extensive test program for our 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 with relevant product standards and verification test methods covering the novel technical aspects of the Salvia product. You document objective evidence to meet the needs of the FDA and the EU Medical Device Regulation. You will be part of our multi-disciplinary development team and collaborate with our engineers to demonstrate the technical performance of our solution and identify areas for improvement. 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.
We offer a challenging position for a Process Development Engineer in our R&D department. Working together with Quality and Operations you will validate new manufacturing processes for our innovative active implantable medical device. You will develop and execute required validations in line with regulatory requirements, including Equipment, Process & Product validations (IQ/OQ/PQ). You enjoy working at the heart of a multi-disciplinary and dynamic scale-up environment. Most importantly, you bring a can-do attitude and have a sharp eye for quality, partnering up with the team to ensure timely realization of Salvia’s manufacturing line.
• Establish and maintain master validation plans for in-house production, including,
control plans, gauge R&R, test method validations, process flows, maintenance and qualification
• Collaborate with the external manufacturing partners in validating the supply chain.
• Grow with the organization to enable Design Transfer to commercial-stage operational processes
and provide continued engineering leadership in scale-up phase.
• 5 years medical device engineering / manufacturing experience.
• Strong technical understanding of validation of manufacturing processes. Experience with
Statistical methods is highly desirable.
• Prior experience in medical device assembly including cleaning, silicone molding, and interconnect
technologies, is considered an advantage.
• MSc or BSc degree in engineering.
Marktconform salary and terms. Salvia BioElectronics offers you a challenging job with a lot of freedom for the future and enough opportunities to grow. The company is a very progressive start-up company with a nice family culture and a great product to work on for helping people who are facing migraine.
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 oth6er 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.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.