Senior Director Medical Device Program Lead (m/f/d)

With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.

In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.

  • Lead a team of cross functional device experts including Device project leads, Human Factor and Risk Management,...
  • Lead definition of device development strategy in partnership with key internal stakeholders. Ensure implementation of Quality Management System within Fresenius Kabi SwissBioSim
  • Lead cross-functional exercises to define targeted device profiles.
  • Develop device development project plans and budget with internal and external cross functional teams.
  • Deliver quality products and processes with appropriate validation and regulatory documentation.
  • Report and tightly control device development timelines, budget and risks to biosimilars project development team.
  • Act as the main interface between the biosimilars project development teams and the subteams (e.g. medical devices, manufacturing & supply, etc.) as well as device vendors.
  • Provide technical and business inputs to projects. Analyze risks and suggest mitigation plans.
  • Oversee device development, manufacturing, validation and regulatory activities.
  • Proactively anticipate and identify risk areas and alert stakeholders appropriately.
  • Report and escalate to management potential issues as needed.
  • Identify new device opportunities
  • Bachelor’s degree (or equivalent) in an applicable Product design, Mechanical, Process, Materials Science or Electronic Engineering field.
  • 5+ years of experience in project management
  • 10+ years of experience in device development with an understanding of device safety, regulatory requirements, policies and procedures.
  • Deep technical understanding of device design, validation, verification and their link to other drug development activities (clinical, manufacturing, commercial, etc.) in the overall drug development plan.
  • Experience in FDA regulated medical devices, Standalone CE marked devices and combination drug device products.
  • Track record of resolving issues in a matrix organization.
  • Strong interpersonal and relationship building skills with the ability to establish a trusted role with the various stakeholders.
  • Solid organizational skills including attention to detail and multi-tasking skills.
  • Effective verbal and written communication.
  • Fluent in English, both oral and written; additional languages (German or French) are an asset.
  • Managerial experience
  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Projektmanagement
  • Arbeitsverhältnis:
  • Unbefristet / Vollzeit
  • Unternehmensbereich:
  • Fresenius Kabi
  • Standort:
  • International / Eysins
  • Bewerbungsfrist:
  • none - we look forward to your application
Amélie Curchod
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 45648

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

Senior Director Medical Device Program Lead (m/f/d)

With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.

In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.

Your assignments

  • Lead a team of cross functional device experts including Device project leads, Human Factor and Risk Management,...
  • Lead definition of device development strategy in partnership with key internal stakeholders. Ensure implementation of Quality Management System within Fresenius Kabi SwissBioSim
  • Lead cross-functional exercises to define targeted device profiles.
  • Develop device development project plans and budget with internal and external cross functional teams.
  • Deliver quality products and processes with appropriate validation and regulatory documentation.
  • Report and tightly control device development timelines, budget and risks to biosimilars project development team.
  • Act as the main interface between the biosimilars project development teams and the subteams (e.g. medical devices, manufacturing & supply, etc.) as well as device vendors.
  • Provide technical and business inputs to projects. Analyze risks and suggest mitigation plans.
  • Oversee device development, manufacturing, validation and regulatory activities.
  • Proactively anticipate and identify risk areas and alert stakeholders appropriately.
  • Report and escalate to management potential issues as needed.
  • Identify new device opportunities

Your profile

  • Bachelor’s degree (or equivalent) in an applicable Product design, Mechanical, Process, Materials Science or Electronic Engineering field.
  • 5+ years of experience in project management
  • 10+ years of experience in device development with an understanding of device safety, regulatory requirements, policies and procedures.
  • Deep technical understanding of device design, validation, verification and their link to other drug development activities (clinical, manufacturing, commercial, etc.) in the overall drug development plan.
  • Experience in FDA regulated medical devices, Standalone CE marked devices and combination drug device products.
  • Track record of resolving issues in a matrix organization.
  • Strong interpersonal and relationship building skills with the ability to establish a trusted role with the various stakeholders.
  • Solid organizational skills including attention to detail and multi-tasking skills.
  • Effective verbal and written communication.
  • Fluent in English, both oral and written; additional languages (German or French) are an asset.
  • Managerial experience

Ihr Kontakt

Amélie Curchod
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 45648

Karrierelevel
Berufserfahrene
Einsatzbereich
Projektmanagement
Arbeitsverhältnis
Unbefristet / Vollzeit
Unternehmensbereich
Fresenius Kabi
Standort
International / Eysins
Bewerbungsfrist
none - we look forward to your application

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

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