Director, Medical Devices
About Jubilant Radiopharma : is a leading pharmaceutical company specializing in nuclear medicine. Our expertise extends to both diagnostic and therapeutic radiopharmaceuticals, as well as innovative medical devices.
With a commitment to quality and patient care, we play a vital role in advancing healthcare through cutting-edge technologies.
Responsibilities :
As the Director of Medical Devices, you will play a critical role in shaping the future of our medical device portfolio. Your responsibilities will include :
Leadership and Team Management :
- Manage and provide leadership to Medical Device Product Development and engineering teams.
- Collaborate with cross-functional teams involved in Medical Device Development, including Quality, Supply Chain, Manufacturing, and Marketing.
Risk Management :
Mitigate and manage Medical Device Program risks by establishing and executing contingency plans.
Customer-Centric Design :
- Lead and implement customer-centric medical device design programs.
- Work closely with Key Opinion Leaders (KOLs) and participate in clinical experience programs.
Team Building :
- Hire and lead the medical devices engineering team.
- Provide capital and human resource recommendations to support the execution of the Company’s Product Development plan.
Subject Matter Expertise :
Act as a Subject Matter Expert, ensuring compliant and robust medical device development and design history files.
Commercialization :
- Lead the transition from development to commercial launch for medical devices.
- Facilitate the closure of the development gap between drug and device.
Collaboration :
Work collaboratively with Product Marketing & Business Development personnel to define the scope and requirements of potential development projects and product requirements throughout the life cycle of medical device products.
Safety and Compliance :
- Oversee Electrical Safety and EMC testing of Medical Devices as applicable.
- Lead the establishment and management of the engineering and design review board for medical device changes.
- Review proposed design changes and manufacturing process changes for Medical Devices.
- Manage the creation and maintenance of design history files and related risk management files.
- Approve Corrective and Preventive Actions (CAPAs) and investigations.
Qualifications :
- Bachelor’s degree in Electrical / Mechanical Engineering.
- 10 or more years of experience in the Medical Device industry.
- Experience with software-driven medical devices.
- At least 10 years’ experience in the development of software-driven medical devices for the EU or US markets.
- Proven experience managing cross-functional teams.
Why Join Jubilant Radiopharma?
- Be part of a dynamic team at the forefront of medical innovation.
- Contribute to improving patient care through cutting-edge medical devices.
- Competitive compensation and benefits package.
Version Francais
Directeur, Dispositifs médicaux
À propos de Jubilant Radiopharma : est une société pharmaceutique leader spécialisée dans la médecine nucléaire. Notre expertise s’étend aux produits radiopharmaceutiques diagnostiques et thérapeutiques, ainsi qu’aux dispositifs médicaux innovants.
Avec un engagement envers la qualité et les soins aux patients, nous jouons un rôle essentiel dans l'avancement des soins de santé grâce à des technologies de pointe.
Responsabilités :
En tant que directeur des instruments médicaux, vous jouerez un rôle essentiel dans l'élaboration de l'avenir de notre portefeuille de dispositifs médicaux.
Vos responsabilités comprendront :
Leadership et gestion d'équipe :
o Gérer et assurer le leadership des équipes de développement de produits et d'ingénierie des appareils médicaux.
o Collaborer avec des équipes interfonctionnelles impliquées dans le développement des dispositifs médicaux, y compris la qualité, la chaîne d'approvisionnement, la fabrication et le marketing.
Gestion des risques :
o Atténuer et gérer les risques du Programme des instruments médicaux en établissant et en exécutant des plans d'urgence.
Conception centrée sur le client :
o Diriger et mettre en œuvre des programmes de conception de dispositifs médicaux centrés sur le client.
o Travailler en étroite collaboration avec les principaux leaders d'opinion (KOL) et participer à des programmes d'expérience clinique.
Team Building :
o Embaucher et diriger l'équipe d'ingénierie des dispositifs médicaux.
o Fournir des recommandations en capital et en ressources humaines pour appuyer l’exécution du plan de développement de produits de la Société.
Expertise en matière :
o Acte en tant qu'expert en matière de matière, assurant la conformité et la robustesse des dossiers de développement et de conception des instruments médicaux.
Commercialisation :
o Diriger la transition du développement au lancement commercial des dispositifs médicaux.
o Faciliter la fermeture de l'écart de développement entre le médicament et le dispositif.
Collaboration :
o Travailler en collaboration avec le personnel du marketing des produits et du développement des affaires pour définir la portée et les exigences des projets de développement potentiels et des exigences des produits tout au long du cycle de vie des produits médicaux.
Sécurité et conformité :
o Surveiller la sécurité électrique et les essais CEM des instruments médicaux, selon le cas.
o Diriger la création et la gestion du conseil d'examen de l'ingénierie et de la conception pour les changements d'instruments médicaux.
o Examiner les changements de conception proposés et les changements de processus de fabrication des instruments médicaux.
o Gérer la création et la maintenance des fichiers d'historique de conception et des fichiers de gestion des risques connexes.
o Approuver les actions correctives et préventives (APAC) et les enquêtes.
Qualifications :
- Bachelor en génie électrique / mécanique.
- 10 années d'expérience ou plus dans l'industrie des dispositifs médicaux.
- Expérience avec les dispositifs médicaux basés sur des logiciels.
- Au moins 10 ans d’expérience dans le développement de dispositifs médicaux basés sur des logiciels pour les marchés de l’UE ou des États-Unis.
- Expérience éprouvée de gestion d'équipes transversales.
Pourquoi rejoindre Jubilant Radiopharma ?
- Faire partie d’une équipe dynamique à la pointe de l’innovation médicale.
- Contribuer à améliorer les soins aux patients grâce à des dispositifs médicaux de pointe.
- Compensation concurrentielle et prestations.
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