Senior R&D Engineer – Medical Devices / MedTech

<h4>Shape the future of cardiovascular healing</h4><p>At <a target="_blank" href="https://xeltis.com/"><span><strong>Xeltis</strong></span></a>, we develop innovative, bioresorbable vascular implants designed to <strong>support the body’s natural healing processes</strong>.<br><br>Our devices provide temporary mechanical support and gradually resorb, enabling <strong>natural tissue formation over time</strong>. This approach challenges conventional implant design and requires advanced modelling, rigorous engineering, and deep understanding of both mechanics and biology.<br><br>To strengthen our R&D organization, we are looking for a <strong>Senior R&D Engineer</strong> who wants to see advanced simulations and engineering decisions translate into <strong>safe, compliant, and clinically meaningful medical devices</strong>.</p><h4>Why this role exists</h4><p>As Senior R&D Engineer, you provide technical leadership in <strong>Finite Element Analysis (FEA)</strong> and <strong>Computational Fluid Dynamics (CFD)</strong> by defining modelling strategies, critically interpreting externally generated results, and guiding design decisions, design controls, and verification activities for <strong>Class III cardiovascular medical devices.</strong><br></p><p>This role is ideal if you:</p><ul><li><p>Enjoy owning <strong>complex technical challenges</strong></p></li><li><p>Want real influence over <strong>device design and development</strong></p></li><li><p>Are motivated by seeing work move from <strong>concept → verification → clinical validation</strong></p></li><li><p>Are transitioning from <strong>academia or research into medical device industry</strong>, or already have industry experience</p></li></ul><p>You will operate in an international, cross-functional R&D environment with a high level of trust and responsibility.</p><figure><lite-youtube videoid="ZRfiP79QDfQ" title="Play: Video" posterquality="sddefault"></lite-youtube></figure><h4><br>What you’ll work on</h4><p>You will contribute across multiple <strong>Medical Device R&D programs</strong>, including:</p><ul><li><p>Acting as the <strong>FEA / CFD Subject Matter Expert</strong> within Xeltis</p></li><li><p>Defining <strong>modelling strategies</strong> for vascular implants</p></li><li><p>Reviewing and guiding outsourced FEA and CFD analyses</p></li><li><p>Interpreting simulation results and translating them into <strong>clear design recommendations</strong></p></li><li><p>Presenting technical outcomes to R&D leadership and management</p></li><li><p>Designing and developing <strong>bioresorbable cardiovascular implants</strong></p></li><li><p>Concept generation, CAD design, prototyping, and iterative development</p></li><li><p>Developing and validating test methods (FEA, bench testing, pre-clinical studies)</p></li><li><p>Leading <strong>verification and validation</strong> sub-activities</p></li><li><p>Supporting <strong>risk management</strong> and design control activities (ISO 13485, 14791, FMEA)</p></li><li><p>Preparing <strong>audit-ready technical documentation</strong> (Design History Files, drawings, reports)</p></li><li><p>Supporting <strong>regulatory submissions</strong> (MDR/CE, FDA, BSI)</p></li><li><p>Collaborating closely with Regulatory Affairs, Quality Assurance, Operations, and Clinical teams</p></li></ul><p>You will typically manage <strong>multiple projects in parallel</strong>, with autonomy to propose solutions and drive continuous improvement.</p><h4>What makes this role distinctive</h4><ul><li><p>You <strong>define modelling strategies</strong>, not just execute them</p></li><li><p>You have <strong>technical decision autonomy </strong>impacting product design and development</p></li><li><p>You work independently on complex R&D challenges with appropriate support</p></li><li><p>You contribute across the <strong>full medical device product life cycle</strong></p></li><li><p>Your work directly affects <strong>patient safety and long-term clinical outcomes</strong></p></li></ul><h4>Who we’re looking for</h4><p>We welcome candidates from <strong>industry or a hybrid background</strong>.</p><p>You likely bring:</p><ul><li><p>A Bachelor’s degree or higher in Engineering, Biomedical Engineering, or a related science</p></li><li><p>At least 5 years of relevant experience, including a minimum of 3 years in the MedTech industry (preferably with Class II or Class III medical devices)</p></li><li><p>Strong experience in <strong>non-linear FEA and CFD</strong> for medical or vascular devices</p></li><li><p>Experience with <strong>bioresorbable polymers, nitinol, or Co-Cr stents</strong> (strong plus)</p></li><li><p>Experience working in or exposure to <strong>regulated environments</strong></p></li><li><p>Knowledge of <strong>ISO 13485</strong>, and EU/US regulatory pathways (advantage)</p></li><li><p>Experience with <strong>verification & validation</strong>, Design of Experiments, RCA, and risk management (ISO 14971)</p></li></ul><p>Equally important:</p><ul><li><p>You can explain complex analyses clearly to diverse stakeholders</p></li><li><p>You enjoy cross-functional and cross-cultural collaboration</p></li><li><p>You combine analytical depth with pragmatic engineering judgment</p></li><li><p>You care deeply about <strong>quality, compliance, and patient safety</strong></p></li></ul><h4>Why Xeltis?</h4><p>At Xeltis, you’ll find:</p><ul><li><p>A <strong>mission-driven, international MedTech team</strong></p></li><li><p>Real ownership and trust in technical decision-making</p></li><li><p>Exposure to the <strong>entire medical device development journey</strong></p></li><li><p>The opportunity to shape therapies that genuinely change lives</p></li></ul><p>This is not a supporting role.<br>This is a role where <strong>your engineering expertise directly shapes outcomes</strong>.</p><h4>Interested?</h4><p>If our mission resonates with you, even if you don’t meet every requirement, we’d love to hear from you.</p><p>Let’s explore whether your experience, curiosity, and ambition belong at Xeltis.</p>