{"id":764,"date":"2024-07-16T14:03:05","date_gmt":"2024-07-16T14:03:05","guid":{"rendered":"https:\/\/www.xs-innovations.com\/?post_type=jobpost&#038;p=764"},"modified":"2024-07-17T13:39:35","modified_gmt":"2024-07-17T13:39:35","slug":"senior-design-engineer","status":"publish","type":"jobpost","link":"https:\/\/www.xs-innovations.com\/?jobpost=senior-design-engineer","title":{"rendered":"Senior Design Engineer"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>About us<\/strong><\/p>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph\">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>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph\">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>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Job Summary<\/strong><\/p>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph\">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>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Responsibilities<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"has-small-font-size\">Design and develop implantable Class III medical devices from concept to production scale-up.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Create detailed engineering models, drawings, and specifications using relevant CAD software and tools.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Collaborate with cross-functional teams to define product requirements and specifications compliant with medical device regulations and user needs.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Conduct feasibility studies, design of experiments, and simulations to establish robust specifications.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Perform risk assessments and design verification\/validation activities as required throughout the project.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Develop and execute test protocols, documenting findings to demonstrate device performance and compliance with requirements and relevant medical standards and regulations.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Ensure compliance with all relevant regulatory standards (e.g., MDR, 21CFR 820, ISO 13485) and quality management systems.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Participate in design reviews, FMEA sessions, and root cause analyses as needed.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Provide technical support to manufacturing and supply chain teams during the design transfer and production validation process.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Stay updated with industry trends, advancements, and regulatory changes.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Qualifications<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"has-small-font-size\">Bachelor\u2019s or Master\u2019s degree in Mechanical Engineering, Biomedical Engineering, or a related field.<\/li>\n\n\n\n<li class=\"has-small-font-size\">5+ years of full life cycle experience with a proven track record in developing Class III medical devices, e.g. (cardiovascular) implantable devices or &nbsp;ICDs, LVADs, TAVRs, catheters, pacemakers, heart valves, stents, and\/or vascular grafts.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Experience in the mechanical design, prototyping and testing of small parts used in vascular access, cardiac repair, and intervention devices.<\/li>\n\n\n\n<li class=\"has-small-font-size\">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>\n\n\n\n<li class=\"has-small-font-size\">Proficiency in 3D CAD software, particularly SolidWorks, and other design, simulation, and statistical analysis tools.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Experience in developing and conducting design verification testing for the long-term viability of implantable devices and managing external suppliers and vendors.<\/li>\n\n\n\n<li class=\"has-small-font-size\">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>\n\n\n\n<li class=\"has-small-font-size\">Experience writing and delivering reports and technical summaries for clinical submissions and regulatory agencies.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Excellent problem-solving skills and attention to detail.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Effective communication and teamwork abilities.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Ability to work in a fast-paced startup environment and manage multiple projects simultaneously.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Fluency in English; additional European languages are a plus.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>What we offer<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"has-small-font-size\"><strong>Competitive Compensation:<\/strong> Enjoy a competitive salary and equity options that reward hard work and dedication.<\/li>\n\n\n\n<li class=\"has-small-font-size\"><strong>Work-Life Balance:<\/strong> Benefit from flexible working hours and remote work options to fit your lifestyle.<\/li>\n\n\n\n<li class=\"has-small-font-size\"><strong>Innovative Projects:<\/strong> Engage in groundbreaking projects that have a tangible impact on patient lives.<\/li>\n\n\n\n<li class=\"has-small-font-size\"><strong>Dynamic Environment:<\/strong> Thrive in a high-energy, fast-paced startup environment where every day brings new challenges and opportunities.<\/li>\n\n\n\n<li class=\"has-small-font-size\"><strong>Collaborative Culture:<\/strong> Be part of a supportive and inclusive team that values collaboration and diverse perspectives.<\/li>\n\n\n\n<li class=\"has-small-font-size\"><strong>Career Advancement:<\/strong> Access numerous professional growth and development opportunities to enhance your skills and career trajectory.<\/li>\n\n\n\n<li class=\"has-small-font-size\"><strong>Cutting-Edge Technology:<\/strong> Work with the latest technology and resources to push the boundaries of medical innovation.<\/li>\n\n\n\n<li class=\"has-small-font-size\"><strong>Fun and Exciting Atmosphere:<\/strong> Experience the excitement of working in a pioneering medtech startup where your contributions make a real difference.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Join us at XS Innovations and be a part of a team that is revolutionizing healthcare through innovation and dedication.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>About us 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, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"menu_order":0,"template":"","jobpost_category":[8],"jobpost_job_type":[9],"jobpost_location":[6],"jobpost_tag":[],"class_list":["post-764","jobpost","type-jobpost","status-publish","hentry","jobpost_category-engineering","jobpost_job_type-full-time","jobpost_location-leiden"],"_links":{"self":[{"href":"https:\/\/www.xs-innovations.com\/index.php?rest_route=\/wp\/v2\/jobpost\/764","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.xs-innovations.com\/index.php?rest_route=\/wp\/v2\/jobpost"}],"about":[{"href":"https:\/\/www.xs-innovations.com\/index.php?rest_route=\/wp\/v2\/types\/jobpost"}],"author":[{"embeddable":true,"href":"https:\/\/www.xs-innovations.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/www.xs-innovations.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=764"}],"wp:term":[{"taxonomy":"jobpost_category","embeddable":true,"href":"https:\/\/www.xs-innovations.com\/index.php?rest_route=%2Fwp%2Fv2%2Fjobpost_category&post=764"},{"taxonomy":"jobpost_job_type","embeddable":true,"href":"https:\/\/www.xs-innovations.com\/index.php?rest_route=%2Fwp%2Fv2%2Fjobpost_job_type&post=764"},{"taxonomy":"jobpost_location","embeddable":true,"href":"https:\/\/www.xs-innovations.com\/index.php?rest_route=%2Fwp%2Fv2%2Fjobpost_location&post=764"},{"taxonomy":"jobpost_tag","embeddable":true,"href":"https:\/\/www.xs-innovations.com\/index.php?rest_route=%2Fwp%2Fv2%2Fjobpost_tag&post=764"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}