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Frank GRUBE

BIOL

En résumé

Bonjour! Guten Tag! Hello!

Thank you for visiting my profile on Viadeo.

With more than 15 years of experience in shaping Software and System engineering services in industrial-leading companies, I strive today for new ways of evolving in my passion for engineering of safety critical systems and especially medical devices.

Safety-critical systems for me present the unique challenge to merge technology and responsibility while medical devices in particular provide the satisfaction to put innovation to the service of human health.

I bring my technical expertise of developing safety-critical systems in small and large teams, my operational experience of efficiently navigating through the jungle of regulatory requirements and my passion for getting products done.

I reach out for joining forces with smart teams of skilled people in order to turn technical solutions into better devices that “make a difference”.

So if you are
• a health professional with a product-idea but not the engineering competencies to realize it
• a start-up struggling to organize beyond the Proof-of-Concept phase
• a device company in need of shaping your processes for medical device compliance
• a company bringing tools for improving system engineering best-practices

I am looking forward to exchanging with you.

Mes compétences :
Medical Device System / Software Architecture
FDA 21 CFR 820 Design Control
Dispositifs médicaux
ISO 13485 / IEC 62304 / IEC 62366

Entreprises

  • Frenesius Kabi

    maintenant
  • SQualE Consulting - Founder

    2016 - maintenant
  • Alpwise SAS - CTO and Shareholder

    2016 - maintenant
  • AxDaNe - Domain Expert Consultant Medical Devices

    2016 - maintenant
  • Fresenius Kabi - Director R&D, Infusion Systems & Platforms

    2015 - 2016 • Definition of technology and strategic product roadmaps for the Business Unit
    • Expert support for project compliance with CE marking and FDA 510k
  • Fresenius Kabi - Team Manager Systems/Software/Electronics

    2013 - 2015 • Definition of the System- and Software-Architecture for the next generation of Infusion devices and Clinical Protocols
    • Technical support of Regulatory and Quality Department for 510k file
    • Successfully passed FDA inspection in January 2015
  • Fresenius Kabi - SW Groupleader & Project manager Device development

    2007 - 2013 • Definition and implementation of an IEC 62304 -conform SW development process for Medical Devices
    • Techncial expert for subcontractor audits (IEC 13485)
    • Project management of the product development of a Class IIb Medical Device from user requirements definition until production transfer
    • DHF and DMR management compliant for CE and 510k marking
  • Siemens VDO - Technical Leader System Architectures

    Saint-Denis 2000 - 2007

Formations

  • Technische Universität Braunschweig (Braunschweig)

    Braunschweig 1986 - 1993 Diplom-Ingenieur (BAC+5)

Réseau

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