Senior Mechanical Engineer

BeaMed is developing a new surgical platform that will reshape cancer and epilepsy treatments by use of a new image guided laser-based ablation technology. The StingRay Laser System is a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast and lung cancers. The StingRay System combines new fiber optic technology with an advanced laser console and computerized intelligent control that allows an excellent match between the structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage. The console integrates advanced imaging modalities, and guides the physician, making sure the treatment is adjusted to the specific patient needs with real time energy control. Primary Job Responsibility: Responsibility for multi-disciplinary development and integration of BeaMed’s core platform for brain surgery including laser, optical fibers, cooling system, and software/mechanical driven control system which integrates into the MRI suite Management of in-house mechanical engineering development activities Integration of all product elements on a system level, including all verification and validation testing for 510k submission Transition of final product to manufacturing, including process validations, DMR generation Support of product related regulatory needs for FDA and CE clearances Performance of all R&D activities under the company’s ISO13485 Design Control Policy system Job Requirements At least 7 years of relevant and meaningful experience in core R&D management of medical devices, specifically mechanical engineering tasks and activities, out of which at least 5 in a ISO13485 certified company that is manufacturing and shipping products Specific experience with surgical disposables, lasers and fibers, a strong plus Knowledge and experience with R&D activities and transfer to manufacturing under ISO13485 Bachelor's level education in mechanical engineering (Masters a plus), academic excellence a strong plus Proven ability to execute and manage R&D activities effectively under tight timelines Detail oriented with very strong analytical skills Can-do attitude, resourceful, hands-on, with excellent interpersonal and team skills