First In Human patients implanted successfully
Arnaud started his career as a research engineer at Air Liquide in 1997. In 1998, he joined Medtronic, where he had the opportunity where he developed his expertise. A senior executive with more than 17 years of experience managing sales, marketing, clinical, personnel, and merchandising at district and regional levels, Arnaud completed his academic training with an MBA from IAE Paris and a graduate from HEC Start-Up. His taste for an entrepreneurial way led him to co-found FineHeart in 2010.
Inventor of the device (I.C.O.M.S.), Head of research on pre-clinical and clinical trials. Electrophysiological surgeon at the private St Augustin heart center in Bordeaux. Researcher in cardiology at the Bordeaux Medical University. Specialist in heart failure electrical treatments and hemodynamics (ventricular assist devices). Ex vice-president of the worldwide scientific congress of electrophysiology and cardiac stimulation – CARDIOTISM.
Virginie is a regulatory affairs and quality manager with more than 15 years of experience in healthcare product sector. She is also experienced in quality management system, project management and regulatory strategies. Virginie joined FineHeart in October 2017.
Before joining FineHeart, Guillaume was Technical and R&D Director at Pixium Vision for more than 9 years. His expertise and passion were instrumental in the development of the PRIMA retinal implant, which is now in its commercialization phase. Prior to that, he held several strategic management positions at GE Healthcare in Europe for more than 25 years, before becoming Technical Director of the Interventional Cardiology Department. Guillaume holds an engineering degree from Ecole Polytechnique in applied mathematics, and from Ecole Nationale Supérieure des Télécommunications de Paris in image processing and computer science.
Sophie is a medical device manufacturing and supply chain specialist. For 15 years, she held various positions at Zimmer Biomet in the orthopedic implant activity, during the industrialization process, and then production management and distribution before heading up Manufacturing Operations for spinal implants and instruments for EMEA. She started her career as a Manufacturing Process Engineer at Hemodia. Sophie Jonquière is an engineer, Materials Science and Engineering from INSA Lyon, and a graduate of IAE Bordeaux, Business Management.
Samuel is a biomechanical engineer he has directed for more than 15 years R&D, industrialization and international marketing of innovative medical devices.
Cyril has more than 15 years of experience in product development of class IIB life sustaining medical device (ResMed). His key competencies are the design of complex systems, software and hardware development of critical system, and the management of medical device development activities.
Docteur Barandon is a cardiac surgeon, professor in Bordeaux Medical University, head of the department of cardiac transplantation and Mechanical Circulatory Support in CHU de Bordeaux since 2010. His clinical activity is especially focused in heart failure patients (acute and chronic) including temporary circulatory support, LVAD and artificial hearts with a special topic in mini-invasive procedures. Docteur Barandon has a strong experience in experimental research, especially focused on myocardial ischemia and heart failure and has developed several experimental models of heart failure in big animals.
Chief of the Cardiac Surgery Division at the University of Pennsylvania Medical Center and Professor of Surgery at the University of Pennsylvania School of Medicine. He is the Surgical Director of Heart Transplantation and Ventricular Assist Programs. He maintains an active surgical practice focusing on the care of patients with end-stage heart failure, coronary artery disease and valvular disease. He is a national leader in the use of mechanical assist devices as a bridge to transplantation or as permanent therapy for end-stage heart failure.
In charge of FineHeart animal experiments (ICOMS FLOWMAKER®) and Delivery System. Cardiologist at CHU (Hospital) in Bordeaux, President of CARDIOSTIM Created the cardiac resynchronization in 1994, a market that amounts to $3 Billion per year. Co-chairman of LIRYC, The Institute of Rythmology and Cardiac Modelling, directed by Pr. Michel Haissaguerre.
Medical Director of the BWH Heart and Vascular Center and Executive Director of the Collaborative Center for Advanced Heart Disease, Brigham and Women’s Hospital and is a Professor of Medicine at Harvard Medical School. Additionally, he is Editor-in-Chief, The Journal of Heart and Lung Transplantation. Dr. Mehra has authored and published over 400 book chapters, manuscripts, editorials and abstracts focusing on all aspects of advanced heart failure and cardiac transplantation, treatment modalities, medical therapies and alternatives to transplantation.
Inventor of the device (I.C.O.M.S.), Head of research on pre-clinical and clinical trials. Electrophysiological surgeon at the private St Augustin heart center in Bordeaux. Researcher in cardiology at the Bordeaux Medical University. Specialist in heart failure electrical treatments and hemodynamics (ventricular assist devices). Ex vice-president of the worldwide scientific congress of electrophysiology and cardiac stimulation – CARDIOTISM.
Cardiac Surgeon with over 25 years of surgical experience in the field of cardiac surgery and has performed over 5000 complex open heart procedures that include implantation of ventricular assist devices, total artificial hearts, heart transplant procedures, coronary revascularizations, removal of cardiac tumors, valve repair and replacement, septal myectomies, repair of left ventricular aneurysms, repair of aortic aneurysms, pulmonary thromboendarderectomies and thromboembolectomies. He is the Otto Gago, MD Endowed Professor of Cardiac Surgery in the Department of Cardiac Surgery at the University of Michigan Medical School as well as the Surgical Director of the Heart Transplant Program and Director for the Center for Circulatory Support in the Department of Cardiac Surgery. His research focuses primarily on the use of mechanical circulatory support in the treatment of end-stage heart disease and research in the field of stem cell therapies.
A venture capitalist passionate about innovation and entrepreneurship, Alexandre has over 20 years’ experience in investment and entrepreneurship, including 14 years in the United States, in Boston (MA).
Alexandre has invested in some twenty seed and venture capital companies.
Among the companies he has supported since his return to France are startups in MedTech (FineHeart, Robocath, Reev), Artificial Intelligence (Thérapixel), Cell Therapy (Cell Easy), low-carbon aviation (Ascendance), low-carbon cement (MaterrUp), the circular economy and waste heat recovery (WaterHorizon) and AgTech (Toopi Organics, Abelio).
Alexandre began his career in Boston in the biotech sector, before co-founding a company dedicated to the consulting and deployment of digital strategies. He then took part in the development of Cue Ball Capital and M Capital Partners, for which he raised €130m from institutional investors.
Alexandre is a graduate of Harvard University (MBA ’98) and the University of Paris (Descartes – Paris Cité Université)
André-Jacques Auberton-Hervé is President of LinKinVax, Chairman Emeritus & Founder Soitec, which he founded in 1992 and ran for 23 years. He is President of 4A Consulting & Engineering
Highly involved in the emergence and structuring of innovative industries, he sits on the board of several international companies.
Lauak Group is a family owned company specialized in the aeronautics industry. With an annual turnover of €200 million and 1830 employees, it has a worldwide manufacturing footprint with operations in France, Canada, India, Mexico and Portugal.
Arnaud started his career as a research engineer at Air Liquide in 1997. In 1998, he joined Medtronic, where he had the opportunity where he developed his expertise. A senior executive with more than 17 years of experience managing sales, marketing, clinical, personnel, and merchandising at district and regional levels, Arnaud completed his academic training with an MBA from IAE Paris and a graduate from HEC Start-Up. His taste for an entrepreneurial way led him to co-found FineHeart in 2010.
Maria Berkman, MD from the UCLA School of Medicine, MBA from the Anderson School of Management at UCLA. Maria is a Director and Head of the MedTech practice at Broadview Ventures. She shares responsibility for all aspects of Broadview’s investment activity, from identification and screening of new opportunities, through due diligence, negotiation of deal structure, and portfolio company board involvement. Prior to joining Broadview Ventures, Maria was a management consultant at Monitor Group (now Monitor Deloitte), and before that, Maria trained within the Partners HealthCare System at Newton Wellesley Hospital in General Surgery. Maria serves on the boards of 480 Biomedical, Adient, BioKier, Cardialen, FineHeart, Vascular Graft Solutions, Vectorious, and Zumbro Discovery. In addition to her role at Broadview Ventures, Maria contributes time as a SBIR/STTR grant reviewer for the National Science Foundation and is a Strategic Advisory Board Member for the RAD BioMed Accelerator in Tel Aviv, Israel.
Bertrand is a Physics Engineer cumulating 20 years of experience in High Tech companies (from startups to larger groups) in global environments (Europe, US, Asia). He developed several breakthrough technologies from proof of concept to high volume markets, with industrialization transfers (low & high volumes) and QA management responsibilities (qualification, reliability, quality systems, international audits), in the field of Microsystems, Optics and Consumer Electronics, and more extensively in the implantable medical devices industry (10 years as R&D Manager for SORIN/LIVANOVA) putting on the market 10+ families of pacemakers and implantable defibrillators. Bertrand holds 12 patents, and funded his own startup in 2016 developing unprecendeted Titanium based MEMS components for the medical industry. In parallel, he is bringing his technical, managerial business expertise and leadership skills as a senior consultant for DOLIAM, a French group investing in highly innovative medical solutions.
More than 20-years of experience as a key account manager in « Cardiology Rhythm Management division » for EDWARDS, SORIN GROUP, and MEDTRONIC. Expert in Pacemaker, ICD, and Resynchronization therapies market development. Co-founder and manager of STIMUPRAT EDITIONS and EDUPRAT TRAINING companies dedicated to entirely new numerical medical education methods.
Over 30 years of international leadership experience in the medical device industry, where he developed early-stage companies, participated in an Initial Public Offering, and led several mergers, acquisitions, and financing rounds. Dr. Boulnois’ focus has been on managing high growth opportunities, either through innovation, unique business models, or strategic expansion. He is co-author of five books and more than 35 peer-reviewed scientific articles in applied physics and biophysics. He is bi-national, American and French.
An engineer by training and a graduate of EIGSI and ESC Bordeaux, Pierre ARNAUD began his career in 2002 in the automotive industry. For 8 years, he held management positions in purchasing and quality within three leading equipment manufacturers, particularly in the PSA and Fiat groups. After a master’s degree in business school, Pierre joined Sodica Corporate Finance (Crédit Agricole Group) in Bordeaux where he advises business leaders on their top-of-the-line issues. It will put at their service its dual industrial and financial competence, he will carry out several operations of sale, acquisition, fundraising, LBO between 2010 and 2014. Pierre joined the GALIA Gestion team in 2015 as Account Manager, then as Director of Investments since January 2018.
Jean-Michel is a partner at IRDI SORIDEC GESTION in the venture capital practice since 2003. He serves on the boards of several portfolio companies such as Gamamabs, FineHeart, EnobraQ, Aelis Farma, Exagan, Ixaltis, Advicenne and LNC Therapeutics. Before joining IRDI SORIDEC Gestion, Jean-Michel spent 4 years with CDP capital’s Life Science venture capital team based first in Montreal and then in Paris. In this position, he made a range of international investments mostly in the US. Before joining CDP Capital, he worked for a regional fund based in Montreal. Jean-Michel graduated from Chimie ParisTech and holds an MSc degree from Montreal university and MBA from McGill.
In charge of FineHeart animal experiments (ICOMS FLOWMAKER®) and Delivery System. Cardiologist at CHU (Hospital) in Bordeaux, President of CARDIOSTIM Created the cardiac resynchronization in 1994, a market that amounts to $3 Billion per year. Co-chairman of LIRYC, The Institute of Rythmology and Cardiac Modelling, directed by Pr. Michel Haissaguerre.
FineHeart S.A, start-up innovante dans le domaine cardiaque, est située à Pessac, en métropole Bordelaise. Son nouveau dispositif médical, l’ICOMS Flowmaker® (Intra Cardiac Output Management System), est une pompe intracardiaque, permettant à des patients souffrant d’insuffisance cardiaque sévère, de les aider à compléter leur fraction d’éjection native par cycle cardiaque. Ce dispositif combine l’expertise de deux célèbres cardiologiques et le savoir-faire de talentueux ingénieurs dans les domaines mécaniques, électroniques et automatiques.
Site Internet : www.fineheart.fr
Le département
Au sein du département Qualité & Affaires Réglementaires et sous la responsabilité directe de la Directrice Qualité & Affaires Réglementaires, vous intégrerez une équipe dynamique et motivée, vous serez moteur dans l’animation du système Qualité et vous pourrez relever le défi d’un projet innovant. L’équipe est composée à ce jour de 4 personnes :
Le poste
En rejoignant notre équipe, vos missions principales seront les suivantes (liste non exhaustive) :
Le profil recherché
– Issue d’une formation d’Ingénieur ou équivalent (Bac + 5)
– Expérience d’au moins 5 ans en tant qu’Ingénieur Qualité dans le monde du DM
– Une 1ère expérience en lien avec les US (et la FDA) serait souhaitable
Les compétences recherchées
– Maitrise des normes et textes réglementaires liés aux Dispositifs Médicaux (ISO 13485, MDR 2017/745, 21CFR, etc…)
– Très bon niveau d’Anglais
– Organisé(e), autonome et rigoureux(se)
– Excellent relationnel, aimer travailler en équipe et viser l’adhésion des équipes
– Esprit d’analyse et de synthèse
Les avantages de FineHeart
Type d’emploi : Temps plein, CDI
Statut : Cadre
Salaire : 45 000,00€ à 47 000,00€ par an
Avantages :
Horaires :
Rejoignez nous rh@fine-heart.com
FineHeart S.A, start-up innovante dans le domaine cardiaque, est située à Pessac, en métropole Bordelaise. Son nouveau dispositif médical, l’ICOMS (Intra Cardiac Output Management System), est une pompe intracardiaque, permettant à des patients souffrant d’insuffisance cardiaque sévère, de les aider à compléter leur fraction d’éjection native par cycle cardiaque. Ce dispositif combine l’expertise de deux célèbres cardiologues et le savoir-faire de talentueux ingénieurs dans les domaines mécaniques, électroniques et des automatismes.
Pour accompagner notre développement, nous cherchons à pourvoir en CDI un poste de : Technicien(ne) de Production Dispositifs Médicaux.
La personne recrutée travaillera sous la supervision directe du Process Department Team Leader, dans le département mécanique de FineHeart.
En nous rejoignant, vous vous verrez confier les missions suivantes :
1. Réalisation d’opérations manuelles sur des composants de dispositifs médicaux implantables.
a. Polissage des pièces (Alliage de titane, PEEK) avec contrôle visuel sous binoculaire. Le procédé de polissage nécessite un travail manuel de précision qui permet d’obtenir une qualité Poli Miroir.
b. Nettoyage des pièces et entrée en salle blanche ISO 7.
c. Travail en salle blanche :
2. Réalisation de la surveillance et maintenance de la salle blanche.
3. Participation à la qualification/validation des nouveaux équipements et/ou outillages.
Compétences et profil recherché
Type d’emploi : Temps plein, CDI
Salaire : 22 000,00€ à 26 000,00€ par an
Avantages :
Horaires :
Rejoignez nous contact@fine-heart.com
Au sein du département Qualité & Affaires Réglementaires et sous la responsabilité directe de la Directrice Qualité & Affaires Réglementaires, vous intégrerez une équipe dynamique et motivée, vous serez moteur dans l’animation du système Qualité et vous pourrez relever le défi d’un projet innovant. L’équipe est composée à ce jour de 4 personnes :
En rejoignant notre équipe, vos missions principales seront les suivantes (liste non exhaustive) :
Profil recherché :
– Issue d’une formation d’Ingénieur ou équivalent (Bac + 5)
– Expérience d’au moins 5 ans en tant qu’Ingénieur Qualité dans le monde du DM
– Une 1ère expérience en lien avec les US (et la FDA) serait souhaitable
Compétences recherchées :
– Maitrise des normes et textes réglementaires liés aux Dispositifs Médicaux (ISO 13485, MDR 2017/745, 21CFR, etc…)
– Très bon niveau d’Anglais
– Organisé(e), autonome et rigoureux(se)
– Excellent relationnel, aimer travailler en équipe et viser l’adhésion des équipes
– Esprit d’analyse et de synthèse
Type d’emploi : Temps plein, CDI
Statut : Cadre
Salaire : 45 000,00€ à 47 000,00€ par an
Avantages :
Exigences linguistiques flexibles :
Horaires :
Rejoignez nous contact@fine-heart.com
FineHeart S.A, est une start-up innovante dans le domaine cardiaque, située à Pessac, en métropole bordelaise. Elle développe principalement l’ICOMS (Intra Cardiac Output Management System), une pompe intracardiaque innovante, permettant à des patients souffrant d’insuffisance cardiaque sévère, de gagner en espérance de vie et de retrouver un confort de vie. Fondée par des médecins et ingénieurs, c’est une technologie alliant mécanique, électronique et informatique au service de la clinique afin de proposer une alternative complètement nouvelle aux assistances cardiaques classiques par une approche plus physiologique et donc plus adaptée au patient. http://fineheart.fr/the-technologie/
Mission
Dans le cadre d’un stage entre 4 et 6 mois, nous recherchons un : Stagiaire logiciel (H/F)
Vous aurez comme mission de mettre en place un outil d’automatisation des rapports de tests logiciels (TU & TI) en se basant sur l’environnement existant et une validation de l’environnement de développement.
Au sein de l’équipe logicielle et sous la responsabilité du scrum master de l’équipe logicielle de 6-8 personnes, spécialisée dans le développement du logiciel embarqué pour le médical.
Les plus du stage : ce stage vous permettra de découvrir un domaine d’application complexe et de pratiquer l’ingénierie logicielle, l’intégration et la validation dans un environnement professionnel de pointe. Possibilité d’embauche à l’issue du stage, dans une société de taille intermédiaire favorisant le travail en équipe et l’initiative.
Compétences et profils recherchés
Compétences techniques
Environnement : Scrum, Git, JIRA, intégration continue, Doxygen, Eclipse, gcc/iar, logiciel embarqué dans le médical – norme 62304
Soft skills
Rémunération
Gratification 3,90€ net de l’heure
Jours RTT employeur offerts
Tickets-restaurant
Date d’embauche
Février/Mars 2023
Type d’emploi : Stage, Temps plein
Avantages :
Programmation :
Lieu du poste : Un seul lieu de travail
Rejoignez nous contact@fine-heart.com
FineHeart S.A, start-up innovante dans le domaine cardiaque, est située à Pessac, en métropole Bordelaise et à Tour. Son nouveau dispositif médical, l’ICOMS (Intra Cardiac Output Management System), est une pompe intracardiaque, permettant à des patients souffrant d’insuffisance cardiaque sévère, de les aider à compléter leur fraction d’éjection native par cycle cardiaque. Ce dispositif combine l’expertise de deux célèbres cardiologiques et le savoir-faire de talentueux ingénieurs dans les domaines mécaniques, électroniques et automatiques.
Dans le cadre d’un contrat à durée indéterminée pour notre site de Bordeaux, nous recherchons un : Technicien en électronique
Au sein de notre équipe électronique et sous la responsabilité du manager du département électronique, vous participez aux tests des éléments électroniques de l’ICOMS, aux tests d’intégration, et au développement de bancs de test.
Dans ce cadre vos missions sont :
Compétences recherchées
Type d’emploi : CDI
Salaire : 24 000,00€ à 35 000,00€ par an
Avantages :
Horaires :
Rejoignez nous contact@fine-heart.com