Senior Process Engineer

<h4><strong>Help shape the future of regenerative cardiovascular therapy</strong></h4><p>At <a target="_blank" href="www.xeltis.com">Xeltis</a>, we are developing a new class of <strong>regenerative cardiovascular implants</strong> designed to restore natural function, not replace it. Our technology is grounded in Nobel Prize, winning science and supported by leading global healthcare investors.<br><br>We are a <strong>medical device company</strong>, operating in one of the most demanding regulatory and technical environments in healthcare. That means complexity, responsibility, and real impact. It also means that the quality of our people and processes matters a lot.</p><h4><strong>Your role</strong></h4><p>As an experienced Black belt <strong>Senior Process Engineer</strong> you will play a crucial role in the characterisation and optimization of manufacturing processes for our Class 3 medical devices. You will work collaboratively with cross-functional teams to ensure compliance with regulatory standards, drive continuous improvement initiatives, improve yield and efficiency and complete validation activities for new and existing equipment and processes.<br></p><p><strong>What you’ll be responsible for:</strong></p><ul><li><p><strong>Key Responsibilities:</strong></p><ul><li><p><strong>Process Improvement:</strong> Characterise and improve our existing processes using your six sigma / lean tool kit to enable high CPK/ PPK.</p></li><li><p><strong>Process Development:</strong> Design and implement robust manufacturing processes to ensure scalability and reproducibility with high yields.<span> </span></p></li><li><p><strong>Continuous Improvement:</strong> Initiate and lead Lean Six Sigma projects to drive efficiency and yield improvements, waste reduction, and cost savings in manufacturing processes.</p></li><li><p><strong>Troubleshooting & Optimization:</strong> Identify and resolve process-related issues, utilizing root cause analysis methodologies to optimize production efficiency and product quality.</p></li><li><p><strong>Cross-Functional Collaboration:</strong> As part of the operations team, you will work closely with R&D, Quality Assurance, Regulatory Affairs, to ensure seamless integration of new processes and technologies into production.</p></li><li><p><strong>Validation & Compliance:</strong> Lead the process validation activities in accordance with FDA and ISO regulations. Prepare and review validation documentation including protocols and reports.</p></li><li><p><strong>Documentation:</strong> Maintain comprehensive documentation for process design, changes, and validations in compliance with regulatory requirements.</p></li><li><p><strong>Training & Mentorship:</strong> Provide training and guidance to junior engineers and production staff on best practices, process improvements, and troubleshooting techniques.</p></li></ul><figure><lite-youtube videoid="ZRfiP79QDfQ" title="Play: Video" posterquality="sddefault"></lite-youtube></figure></li></ul><h4><strong>What you bring</strong></h4><ul><li><p><strong>Experience:</strong> Minimum of 5-7 years of industrial experience in process engineering within the medical device industry.</p></li><li><p><strong>Education:</strong><span> </span>Master’s or bachelor’s degree with significant industrial experience in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.</p></li><li><p><strong>Technical Skills: </strong>Experience with process validation methodologies and statistical analysis tools. Experience with Electrospinning is a plus.</p></li><li><p><strong>Problem-Solving:</strong> Excellent analytical and troubleshooting skills with a data-driven approach to process optimization.</p></li><li><p><strong>Regulatory Knowledge:</strong> Strong understanding of FDA regulations, ISO standards, and Good Manufacturing Practices (GMP).</p></li><li><p><strong>Communication:</strong> Strong verbal and written communication skills, with the ability to present technical information clearly to diverse audiences.</p></li><li><p><strong>Team Player:</strong> Proven ability to work collaboratively in a fast-paced, cross-functional environment.</p></li></ul><h4><strong>Why Xeltis</strong></h4><p>At Xeltis, you won’t just optimise processes, you’ll help define them at a pivotal moment in the company’s journey. <br><br>We offer:</p><ul><li><p>A senior, impactful role with real ownership and visibility</p></li><li><p>A collaborative, international scale-up environment</p></li><li><p>Competitive salary and benefits</p></li><li><p>The opportunity to contribute directly to technology that changes patients’ lives</p></li></ul><h4><strong>Interested?</strong></h4><p>If you are a senior process engineer who wants to apply deep technical expertise to a challenge that truly matters - and who is motivated by ownership, complexity, and impact - we would like to meet you.<br><br>At Xeltis, your work will directly contribute to restoring natural cardiovascular function for patients worldwide.<br>If this role feels like the right next step, we invite you to apply and explore whether Xeltis is where your expertise can make the greatest difference.<br></p>