<div> <p><strong>About us</strong></p> <p>Globally, 2.5 million patients rely on kidney dialysis machines three times a week as their lifeline. The high blood flow needed for these three-hour sessions is achieved through a surgically created connection between an artery and a vein in the arm. This permanent connection and continuous high blood flow lead to frequent complications, requiring at least bi-annual follow-up surgeries for each patient.</p> <p>XS-Innovations, a pioneering medtech startup based in Leiden, is dedicated to drastically improving the quality of life for kidney patients. We are developing a cutting-edge Class III implantable valve that opens the connection between the artery and vein only when needed during dialysis. This device will be the first in a series of innovative, reliable, and life-saving technologies related to vascular access. We seek passionate and skilled Design Engineers to join our dynamic team and contribute to the next generation of medical devices.</p> <p><strong>Job Summary</strong></p> <p>As a Senior Design Engineer, you will be instrumental in developing a cutting-edge Class III implantable device for treating End Stage Kidney Disease (ESKD). You will collaborate with engineering partners and cross-functional teams, including R&amp;D, Quality &amp; Regulatory, Clinical, Test, and Manufacturing, to ensure our products meet the highest standards of safety, efficacy, and quality.</p> <p><strong>Responsibilities</strong></p> <ul> <li>Design and develop implantable Class III medical devices from concept to production scale-up.</li> <li>Create detailed engineering models, drawings, and specifications using relevant CAD software and tools.</li> <li>Collaborate with cross-functional teams to define product requirements and specifications compliant with medical device regulations and user needs.</li> <li>Conduct feasibility studies, design of experiments, and simulations to establish robust specifications.</li> <li>Perform risk assessments and design verification/validation activities as required throughout the project.</li> <li>Develop and execute test protocols, documenting findings to demonstrate device performance and compliance with requirements and relevant medical standards and regulations.</li> <li>Ensure compliance with all relevant regulatory standards (e.g., MDR, 21CFR 820, ISO 13485) and quality management systems.</li> <li>Participate in design reviews, FMEA sessions, and root cause analyses as needed.</li> <li>Provide technical support to manufacturing and supply chain teams during the design transfer and production validation process.</li> <li>Stay updated with industry trends, advancements, and regulatory changes.</li> </ul> <p><strong>Qualifications</strong></p> <ul> <li>Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.</li> <li>5+ years of full life cycle experience with a proven track record in developing Class III medical devices, e.g. (cardiovascular) implantable devices or ICDs, LVADs, TAVRs, catheters, pacemakers, heart valves, stents, and/or vascular grafts.</li> <li>Experience in the mechanical design, prototyping and testing of small parts used in vascular access, cardiac repair, and intervention devices.</li> <li>Proficiency in materials science, including experience with metals and polymers commonly used in implantable and delivery devices (e.g., stainless steels, nickel-titanium alloys, tantalum, cobalt-chromium alloys, platinum chromium).</li> <li>Proficiency in 3D CAD software, particularly SolidWorks, and other design, simulation, and statistical analysis tools.</li> <li>Experience in developing and conducting design verification testing for the long-term viability of implantable devices and managing external suppliers and vendors.</li> <li>Familiarity with medical device regulations and standards (e.g., MDR, ISO 13485, ISO 14971, ISO 10993, FDA 21 CFR 820), quality management systems (QMS) and document control processes.</li> <li>Experience writing and delivering reports and technical summaries for clinical submissions and regulatory agencies.</li> <li>Excellent problem-solving skills and attention to detail.</li> <li>Effective communication and teamwork abilities.</li> <li>Ability to work in a fast-paced startup environment and manage multiple projects simultaneously.</li> <li>Fluency in English; additional European languages are a plus.</li> </ul> <p><strong>What we offer</strong></p> <ul> <li> <strong>Competitive Compensation:</strong> Enjoy a competitive salary and equity options that reward hard work and dedication.</li> <li> <strong>Work-Life Balance:</strong> Benefit from flexible working hours and remote work options to fit your lifestyle.</li> <li> <strong>Innovative Projects:</strong> Engage in groundbreaking projects that have a tangible impact on patient lives.</li> <li> <strong>Dynamic Environment:</strong> Thrive in a high-energy, fast-paced startup environment where every day brings new challenges and opportunities.</li> <li> <strong>Collaborative Culture:</strong> Be part of a supportive and inclusive team that values collaboration and diverse perspectives.</li> <li> <strong>Career Advancement:</strong> Access numerous professional growth and development opportunities to enhance your skills and career trajectory.</li> <li> <strong>Cutting-Edge Technology:</strong> Work with the latest technology and resources to push the boundaries of medical innovation.</li> <li> <strong>Fun and Exciting Atmosphere:</strong> Experience the excitement of working in a pioneering medtech startup where your contributions make a real difference.</li> </ul> <p><strong>Join us at XS Innovations and be a part of a team that is revolutionizing healthcare through innovation and dedication.</strong></p> </div>