Senior Design Engineer

pstrongAbout us /strong /pbrWeet u niet zeker welke vaardigheden u nodig heeft voor deze functie? Lees dan de volledige omschrijving hieronder voor een compleet beeld van de kandidaatseisen.brpGlobally, 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. /ppXS-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. /ppstrongJob Summary /strong /ppAs 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 RD, Quality Regulatory, Clinical, Test, and Manufacturing, to ensure our products meet the highest standards of safety, efficacy, and quality. /ppstrongResponsibilities /strong /pulliDesign and develop implantable Class III medical devices from concept to production scale-up. /liliCreate detailed engineering models, drawings, and specifications using relevant CAD software and tools. /liliCollaborate with cross-functional teams to define product requirements and specifications compliant with medical device regulations and user needs. /liliConduct feasibility studies, design of experiments, and simulations to establish robust specifications. /liliPerform risk assessments and design verification/validation activities as required throughout the project. /liliDevelop and execute test protocols, documenting findings to demonstrate device performance and compliance with requirements and relevant medical standards and regulations. /liliEnsure compliance with all relevant regulatory standards (e.g., MDR, 21CFR 820, ISO 13485) and quality management systems. /liliParticipate in design reviews, FMEA sessions, and root cause analyses as needed. /liliProvide technical support to manufacturing and supply chain teams during the design transfer and production validation process. /liliStay updated with industry trends, advancements, and regulatory changes. /li /ulpstrongQualifications /strong /pulliBachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field. /lili5+ 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. /liliExperience in the mechanical design, prototyping and testing of small parts used in vascular access, cardiac repair, and intervention devices. /liliProficiency 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). /liliProficiency in 3D CAD software, particularly SolidWorks, and other design, simulation, and statistical analysis tools. /liliExperience in developing and conducting design verification testing for the long-term viability of implantable devices and managing external suppliers and vendors. /liliFamiliarity 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. /liliExperience writing and delivering reports and technical summaries for clinical submissions and regulatory agencies. /liliExcellent problem-solving skills and attention to detail. /liliEffective communication and teamwork abilities. /liliAbility to work in a fast-paced startup environment and manage multiple projects simultaneously. /liliFluency in English; additional European languages are a plus. /li /ulpstrongWhat we offer /strong /pullistrongCompetitive Compensation: /strong Enjoy a competitive salary and equity options that reward hard work and dedication. /lilistrongWork-Life Balance: /strong Benefit from flexible working hours and remote work options to fit your lifestyle. /lilistrongInnovative Projects: /strong Engage in groundbreaking projects that have a tangible impact on patient lives. /lilistrongDynamic Environment: /strong Thrive in a high-energy, fast-paced startup environment where every day brings new challenges and opportunities. /lilistrongCollaborative Culture: /strong Be part of a supportive and inclusive team that values collaboration and diverse perspectives. /lilistrongCareer Advancement: /strong Access numerous professional growth and development opportunities to enhance your skills and career trajectory. /lilistrongCutting-Edge Technology: /strong Work with the latest technology and resources to push the boundaries of medical innovation. /lilistrongFun and Exciting Atmosphere: /strong Experience the excitement of working in a pioneering medtech startup where your contributions make a real difference. xgiwjmb /li /ulpstrongJoin us at XS Innovations and be a part of a team that is revolutionizing healthcare through innovation and dedication. /strong /pbr