Digital Health Project Manager – SaMD

Details

  • Category: Medical devices
  • Location: German part of Switzerland
  • Starting date: Apr 30, 2020
  • Applications have closed
  • Domain of experience: SaMD
  • Level required: Middle
  • Years of experience: 5+

Your Role

Joining our team of 350 Experts in the Life Sciences Industry, you will be supporting our clients in the Development of SaMD for various Digital Heath Projects, working with on the most innovative technologies.

Your Tasks

In your role as a Digital Health PM Consultant, you are supporting our clients and project teams by:

  • Leading and managing Cross-Functional Digital Health R&D projects through planning, development, and implementation, product launch/commercialization: spanning across areas of Medical Device / Remote Monitoring, Medical Device Connectivity, Digitalization in Clinical Trials, Telemedicine, Digital Medical SW Apps (Diagnosis, Digital Tx, SaMD)
  • Supporting the associated Quality Aspects, from SW Quality, Product Quality, to GxP where relevant
  • Driving project management, cross-functional coordination, and inter/intra team communications to deliver outstanding outcomes
  • Managing complex schedules that may involve both internal and external engineering teams, as well as vendors (OTS), while prioritizing activities for rapid execution of critical path work items
  • Ensuring that the project risks and issues are identified early enough, and are managed and resolved promptly (identifying, managing, documenting and mitigating project risks)
  • Monitoring project progress against timelines, budget and quality requirements of the project
  • Developing corrective action plans and/or leading preplanning efforts to minimize/eliminate variances.
  • Using advanced techniques to anticipate, identify and develop solutions or alternatives to a variety of common and uncommon problems

Your Profile

  • Minimum of 5 - 8 years of experience as a Medical Device or Medical SW Project Manager, executing Digital Health implementation projects, SaMD (Software as Medical Device)
  • Experience in the Medical Devices industry, relevant ISO / IEC / FDA regulations, standards, guidances (e.g. Medical Device and SW classification, IEC 62304, FDA guidance on SaMD, knowledge of ISO 13485 and ISO 14971)
  • Master or Bachelor degree in IT, Engineering or related University studies
  • Strong and demonstrable project management skills: planning & coordinating, communicating & influencing, relationship building, achieving milestones, resolving issues and managing risks
  • Excellent understanding of the Quality / Regulatory requirements
  • Proven experience in product development
  • Able to prioritize work, complete multiple tasks and work under deadline and budget guidelines

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