Lausanne, Vaud, Switzerland
I am a Staff Biocompatibility Engineer at Stryker with over 10 years of experience in the medical device industry, including research, regulatory affairs, and product lifecycle management. My work focuses on driving cross-functional execution across design changes, manufacturing transfers, and global lifecycle activities for complex medical devices. In my current role, I act as a technical lead, coordinating stakeholders across R&D, Quality, Regulatory, and global manufacturing sites to ensure compliant and efficient execution of change control and lifecycle activities. I support risk assessments, nonconformance investigations, and verification strategies, contributing to consistent implementation across multiple sites. I bring strong experience in regulatory activities through my previous role in Regulatory Affairs, where I supported EU MDR remediation for a large portfolio and collaborated closely with labeling, medical affairs, and risk management teams to ensure compliance of product documentation. Earlier in my career, I led multidisciplinary research activities at EPFL, supervising students and managing projects from concept to execution. This experience built a strong foundation in leadership, structured execution, and enabling teams to deliver results.
• Act as technical lead and Subject Matter Expert, coordinating cross-functional stakeholders (R&D, Quality, Regulatory, Manufacturing) to drive alignment, execution, and compliance across change control activities. • Support product transfers (>10 projects), contributing to design change activities, risk assessments, verification strategies, and smooth transition into production. • Contribute to design and process decisions to support material selection, sterilization compatibility, manufacturability, and scalable production using risk-based approaches • Coordinate cross-functional activities across global sites to ensure consistent and aligned execution of change control and lifecycle activities in compliance with global standards - Key achievements: • Completed 540+ Change Impact Assessments with >80% delivered within 48 hours, supporting global operations • Developed and implemented a Power BI dashboard to track performance and improve transparency • Authored 40+ biological safety and risk assessment reports supporting global product compliance and lifecycle management - Technical and analytical skills: • Power BI (dashboard automation), GraphPad Prism, MS Excel (advanced), TrackWise, OnePLM, SharePoint, Microsoft Office applications, AI Copilot tools, Labeling & IFU compliance (EU MDR), Change Control, CAPA, Design Transfer
• Supported EU MDR remediation for the Trauma & Extremities portfolio, covering thousands of SKUs under strict regulatory timelines • Led cross-functional deficiency response activities for MDR certification, coordinating R&D, Quality, Labeling, and other stakeholders to ensure timely and compliant execution • Acted as Regulatory Lead for cobalt/CMR-related material changes, driving regulatory strategy and labeling updates impacting more than 2,000 SKUs • Collaborated closely with labeling, medical, and risk management teams to ensure compliance of product labeling with global regulatory requirements • Translated regulatory requirements into actionable plans, supporting implementation across development and lifecycle activities - Key achievements: • Performance Excellence Award (2021) for leadership and execution of the cobalt/CMR regulatory strategy project
Contributed to regulatory and quality activities supporting the development and compliance of an active Class III neurostimulator device under EU and US regulations. Key responsibilities and contributions: • Supported the implementation of the Quality Management System in accordance with ISO 13485, aligned with the requirements of EU MDR 2017/745. • Assisted in the preparation and submission of clinical trial application dossiers for regulatory approval in both the European Union and the United States.
• Led multidisciplinary research activities, supervising 15+ students and a laboratory technician, ensuring structured execution and delivery of results • Managed research projects from concept to execution, including planning, prioritization, and coordination of workstreams • Collaborated with industry partners, including Medtronic, on studies related to implantable and neurovascular devices • Secured > CHF 100,000 in research funding and managed project resources to deliver results within defined timelines • Developed and optimized biological testing platforms aligned with ISO 10993 principles • Managed laboratory activities including experimental design, assay development, and human biological sample studies in collaboration with clinical partners (CHUV). • Authored and co-authored 20+ peer-reviewed scientific publications in international journals.