Henri FÉRIEN

𝐎𝐩𝐞𝐫𝐚𝐭𝐢𝐨𝐧 𝐌𝐚𝐧𝐚𝐠𝐞𝐫 - 𝐌𝐢𝐭𝐫𝐚𝐥 𝐕𝐚𝐥𝐯𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 Report to : COO (USA) 𝐌𝐚𝐢𝐧 𝐅𝐮𝐧𝐜𝐭𝐢𝐨𝐧𝐬 : ⊳ Operation Strategy Definition - Owner of 18 months Roadmap definition based on clinical and R&D needs as well as CE Mark Activities. Annual Budget: 5 Millions €. ⊳ Manufacturing & Quality Management of 3 main suppliers Worlwide (Forecast Definition, Manufacturing & Transfer, Quality, Components Inventory, Logistics). ⊳ Hands-on and vocal Leader for continuous engineering efforts, resulting in improving the yield from 55% to 90% on Class III Transcather Valve Delivery System. ⊳ Coordinating in-depth between R&D, Quality teams and Manufacturing Supplier based on metrics-driven feedbacks. ⊳ Logistic / Warehouse : Active Technical Leader in brand-new deployment of supporting functions, warehouse/Logistics, including quality system. Sterilization & Clinical Logistic Management from Supplier Warehouse to Clinical Center (full treacability) on 3 continents (USA, Europe - China & Australia). ⊳ Supplier Quality Audit & Reporting / Complaint Management. 𝐌𝐚𝐢𝐧 𝐀𝐜𝐜𝐨𝐦𝐩𝐥𝐢𝐬𝐡𝐦𝐞𝐧𝐭 : ⊳ Production Ramp up (Qty x5) on 5 Class III Cardiologic Devices in 24 Months. ⊳ Ensure the proper manufacturing in time of the quantities required for the advancement of the global HighLife's Clinical Study and its China's partners as well as for the CE Mark Activities. ⊳ Quality Improvements : Final controls Implementation on the clinical batches (5 Clinicals Devices) before lot released (Inspection Procedure redaction, Training, Tools Purchasing, follow-up on iteration). ⊳ Quality Supervision (Troubleshooting, Root Cause Analysis, CAPA & NCMR). ⊳ Process Validation Management with Suppliers (pFMEA, IQ, OQ, PQ).

𝐑&𝐃 𝐏𝐫𝐨𝐣𝐞𝐜𝐭 𝐌𝐚𝐧𝐚𝐠𝐞𝐫 - 𝐌𝐢𝐭𝐫𝐚𝐥 𝐕𝐚𝐥𝐯𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 : ⊳ Development & Transfer of the Ring Implant consolidated version (Class III - Implanted Device). Took a Class III cardiac implant from initial prototypes in January 20 to first clinical implantation in February 21. ⊳ Manufacturing Transfer Management of a Delivery Catheter to a new Supplier abroad (Class III). ⊳ Complete Technology Transfer (5 devices) to China Partner within 12 months during Covid. (Documentation, Device Use training, Proivide Devices for full Design Testings, Clinical Training). 𝐌𝐚𝐢𝐧 𝐅𝐮𝐧𝐜𝐭𝐢𝐨𝐧𝐬 : ⊳ R&D Project Management ( Design development, Prototyping, Cases & Risk Analysis, Process Development, DFMEA, CQV) ⊳ Supplier & Manufacturing Management (Inventory, Forecast, Manufacturing Planification, Timeline). ⊳ Verification & Validation (Design Verification, Animal Testing, Biocompatibily/Sterilisation/Aging study Definition & Management, Product and Process Risks Analysis) ⊳ Quality Supervision (Troubleshooting, Root Cause Analysis, CAPA & NCMR, Inspection Plan Definition). ⊳ CE mark activities Management (protocol, timeline , supplier management, justifications). 𝐏𝐡𝐲𝐬𝐢𝐜𝐢𝐚𝐧 𝐓𝐫𝐚𝐢𝐧𝐢𝐧𝐠 𝐚𝐧𝐝 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐂𝐚𝐬𝐞𝐬 : ⊳ In charge of supporting/training clinical specialists & cardiologist during clinical case (Device clinical preparation, reduce the risk of misuse, providing guidance). ⊳ Physician Training (Catheter use, risk of mishandling, precaution of use) on animal case. ⊳ Preparation of clinical devices during clinical cases. ⊳ Technical and Engineering support on clinical cases.

𝐂𝐫𝐞𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐭𝐡𝐞 𝐍𝐢𝐠𝐡𝐭 𝐒𝐡𝐢𝐟𝐭 (𝐄𝐱𝐭𝐫𝐮𝐬𝐢𝐨𝐧, 𝐁𝐚𝐥𝐥𝐨𝐨𝐧 𝐅𝐨𝐫𝐦𝐢𝐧𝐠, 𝐏𝐥𝐚𝐬𝐭𝐢𝐜 𝐈𝐧𝐣𝐞𝐜𝐭𝐢𝐨𝐧, 𝐂𝐚𝐭𝐡𝐞𝐭𝐞𝐫 𝐀𝐬𝐬𝐞𝐦𝐛𝐥𝐲) Team Management of 11 people on Ballon & Extrusion Area / Recruitment & Training of 8 people. - Weekly Planning based on the Month Forecast / Scheduling Work Orders. Daily Production tasks Management (Team management, troubleshooting, maintenance, training, follow up) - Definition & Layout of a new production clean room / Transfer and Qualification (IQ, OQ, PQ) of 14 Balloon Forming Machines. Strengthen coordination between the Production requirement and the necessity of the validation. - Lean Manufacturing Improvements. Definition and Setting up of Kanban system to manage closely our extrusion planning and Keeping a close look on our current stock. Definition of a Scheduling board on the weekmy manufacturing per machines.

Site Development and Coordination in India (Gurgaon) between Arthesys and his sister company "Degania Medical Device". Full time done in India. - Transfer new catheters, products, machines and equipment between both sites. - Development/Validation of new machines in order to automatized operator dependant process. - Solve daily production/quality issues. - Ensure a technical support on process line, validation and tool/machine development. - Manage documentation alignment between both sites (France and India). - Team training and building to implement Lean manufacturing (5s, 6Sigma).

Missions : Transférer en Inde de nouveaux cathéters et les procédés de fabrication associés. Réalisation : Management dans son entièreté d'un transfert en Inde d'un dispositif médical de classe 3 avec soumission du dossier à l'organisme notifié (9 mois). Cela Consiste en : • Manager et mener à bien des projets complets comprenant des équipes Françaises et Indiennes. • Rédiger la documentation nécessaire au transfert et à la formation des équipes (instructions de fabrication, spécifications, fiche de contrôle). • Préparer les envois à l'étranger. • Former les équipes étrangères aux nouveaux procédés de fabrication. • Coordonner la fabrication des préséries, • Valider les processus de fabrication (IQ,OQ,PQ). • Rédiger les rapports de validations.

• Développement/Amelioration d'un porteur de stent auto-expansible pré-existant. (Conception, Développement, Recherche de solution, Industrialisation, Redaction Documentaire, Formation des équipes, Validation des Process et Mise en production). • Participation à la conception d'un connecteur Y d'angioplastie (Pièce plastique Injecté).