סקירה כללית
Are you passionate about transforming cutting-edge engineering into life-saving medical technologies? At LuSeed Vascular, we’re pioneering next-generation neurovascular embolization solutions that address unmet clinical needs. We are looking for a highly motivated R&D Engineer and Project Manager to join our growing team of innovators dedicated to advancing the treatment of complex intracranial aneurysms. Position Summary: This mid-level role is ideal for an engineering professional with a strong technical foundation in mechanical or biomedical engineering and a proven track record in managing complex projects through full product development cycles. The role integrates hands-on engineering, cross-functional collaboration, and project leadership, with direct impact on clinical performance and patient safety. As part of our R&D team, you will be instrumental in conceptualizing, designing, validating, and delivering high-quality medical devices that comply with global regulatory standards and address real-world clinical challenges. Key Responsibilities: * Lead end-to-end product development processes—from concept to validation—for vascular and neurovascular devices. * Manage multidisciplinary projects, timelines, and milestones across internal teams and external vendors. * Drive mechanical design, prototyping, and iterative development using CAD tools (SolidWorks preferred). * Support design and verification and validation (V&V), ensuring robust design control and regulatory readiness. * Author and review technical documentation for regulatory submissions, risk assessments, and design reviews. * Collaborate with QA/RA teams to support FMEAs, CAPA investigations, and audit preparations. * Engage in supplier and manufacturing interface activities, including component sourcing, test method development, and process qualification. Qualifications and Experience: * B.Sc. in Mechanical or Biomedical Engineering (mandatory). * 3–8 years of experience in R&D or project engineering in a regulated industry, preferably medical devices. * Strong proficiency in SolidWorks and mechanical design for small-scale, high-precision systems. * Hands-on, practical mindset—prototyping, testing, and problem-solving are core to your approach. * Excellent communication skills and the ability to lead cross-functional collaboration. * Fluent in English (spoken and written); comfortable with technical documentation and presentations. * Proficient in Microsoft Office tools (Word, Excel, PowerPoint). Highly Desirable: * Direct experience in medical device design and development (Class II/III preferred). * Familiarity with laser welding, 3D printing, and micro-scale assembly techniques. * Understanding of ISO 13485, IEC 60601, ISO 14971, and FDA 21 CFR Part 820 compliance frameworks. * Knowledge of materials behavior and DFM for polymers, Nitinol, stainless steel, and composite structures. Why Join LuSeed Vascular? At LuSeed, innovation is more than a goal—it’s our mission. We offer the opportunity to work on meaningful, life-enhancing technologies in a fast-paced startup environment. You’ll enjoy high autonomy, strong technical mentorship, and a collaborative team focused on excellence and execution. Apply Now If you’re ready to shape the future of vascular intervention and thrive in a dynamic R&D ecosystem, we want to hear from you
דרישות המשרה
* Lead end-to-end product development processes—from concept to validation—for vascular and neurovascular devices. * Manage multidisciplinary projects, timelines, and milestones across internal teams and external vendors. * Drive mechanical design, prototyping, and iterative development using CAD tools (SolidWorks preferred). * Support design and verification and validation (V&V), ensuring robust
