Salvia job offer

Test and Verification Engineer

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 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.

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? 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 in order 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 emonstrate 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.

Responsibilities

Establish objective evidence of safety and performance of Salvia’s bioelectronic system:

• Translate system requirements into verification program and ensure testability of requirements.

• Develop test cases and develop verification protocols

• Execute verification testing and report on results

• Contribute to the development of inhouse test setups.

• Support test estimation and planning activities.

• Analyzing and post-processing of measurement data by using statistical techniques. Interface with the design

engineers to resolve product problems.

• Interface to external test-houses to ensure products comply to relevant standards.

Your profile

• Several years of (regulated) industry experience in a comparable role, preferably in medical devices.

• Self-starter, naturally taking ownership.

• Critical thinker, structured and strong analytical skills.

• MSc/BSc in electrical engineering, physics, mechanical engineering, mechatronics, or another relevant

discipline.

• Understanding of development process and testing of medical devices (ISO 13485, 21CFR820).

What we offer

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Will you be our new colleague?

Our team is growing and we are always looking for passionate and talented individuals who want to be part of our mission to give people with migraine a better life.

We encourage open applications. Please submit yours here!

Acquisition is not appreciated.

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