Director Of Medical Devices

3 weeks ago


Montréal QC, Canada Brunel Full time

Director, Medical Devices

Montreal, QC

Introduction

We are hiring for a Director of Medical devices, to join a leading pharmaceutical company specializing in nuclear medicine. They have expertise in both diagnostic and therapeutic radiopharmaceuticals, as well as innovative medical devices. They are committed to quality, patient care, and dedicated to advancing healthcare through cutting-edge technologies. As the Director of Medical Devices, you will play a pivotal role in shaping the future of their medical device portfolio. Your responsibilities will include:

Responsibilities

  • 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.
  • Mitigate and manage Medical Device Program risks by establishing and executing contingency plans.
  • Lead and implement customer-centric medical device design programs.
  • Work closely with Key Opinion Leaders (KOLs) and participate in clinical experience programs.
  • 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.
  • Act as a Subject Matter Expert, ensuring compliant and robust medical device development and design history files.
  • Lead the transition from development to commercial launch for medical devices.
  • Facilitate the closure of the development gap between drug and device.
  • 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.
  • 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.

Requirements

  • 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.

What We Offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you:
from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job.

About Us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

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Version Francais

Directeur, Dispositifs médicaux

Montréal, QC

Introduction

L'entreprise 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. En tant que directeur des dispositifs médicaux, vous jouerez un rôle essentiel dans l'élaboration de l'avenir de leur portefeuille de dispositifs médicaux. Vos responsabilités seront les suivantes

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 :
  • Gérer et assurer le leadership des équipes de développement de produits et d'ingénierie des appareils médicaux.
  • 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.
  • Atténuer et gérer les risques du Programme des instruments médicaux en établissant et en exécutant des plans d'urgence.
  • Diriger et mettre en œuvre des programmes de conception de dispositifs médicaux centrés sur le client.
  • Travailler en étroite collaboration avec les principaux leaders d'opinion (KOL) et participer à des programmes d'expérience clinique.
  • Embaucher et diriger l'équipe d'ingénierie des dispositifs médicaux.
  • Fournir des recommandations en capital et en ressources humaines pour appuyer l’exécution du plan de développement de produits de la Société.
  • 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.
  • Diriger la transition du développement au lancement commercial des dispositifs médicaux.
  • Faciliter la fermeture de l'écart de développement entre le médicament et le dispositif.
  • 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.
  • Surveiller la sécurité électrique et les essais CEM des instruments médicaux, selon le cas.
  • Diriger la création et la gestion du conseil d'examen de l'ingénierie et de la conception pour les changements d'instruments médicaux.
  • Examiner les changements de conception proposés et les changements de processus de fabrication des instruments médicaux.
  • Gérer la création et la maintenance des fichiers d'historique de conception et des fichiers de gestion des risques connexes.
  • 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.

Ce que Nous Offrons

Pourquoi postuler via Brunel ? Trouver la prochaine étape de votre carrière peut être un travail à plein temps en soi. Nous gérons le processus pour vous :
de la soumission de votre CV à la coordination des entretiens, à l'extension des offres et à l'assistance à l'intégration. Nous vous mettrons en route pendant que vous vous concentrez sur votre travail.

À Propos de Nous

Brunel a la réputation de travailler avec certains des meilleurs dans le domaine. C'est ce que nous nous efforçons continuellement de faire. Depuis 45 ans, nous avons créé un réseau mondial de clients intéressants et de personnes talentueuses travaillant ensemble à travers une vaste gamme de services.



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