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Technical Lead - Software as Medical Device (SaMD)

Eingestellt von Michael Bailey Associates - Munich

Gesuchte Skills: Support, Design

Projektbeschreibung

For our Medical Device Company we are recruiting for an expert in App Development to support their expanding development of "Software as a Medical Device" (SaMD)

You will be a recognized expert for the development and maintenance of safety critical mobile and/or web applications and will take over the technical leadership for the software development part for projects classified as SaMD.

Responsibilities:

- The role includes early phase development activities, the management and monitoring of software development at external partners, and the commercialization and maintenance of overall life cycle management as legal manufacturer.
- Technical leadership for the software development of mobile and/or web applications classified as SaMD
- Providing software/systems life cycle expertise within a broader cross functional drug product development team
- Supporting the standardization of the entire SaMD life cycle management process in order to utilize cross product synergies
- Leading the collaboration with external development partners:

o Support supplier selection, auditing and approval
o Elaboration of development plans and contracts for upcoming projects
o Monitor work progress according to plan
o Monitor, support and challenge technical development and deliverables as well as change, test and release strategies
o Support the deployment and implementation of a sustainable Product Life Cycle process in close collaboration with external and internal partners and stakeholders - Leading and/or supporting cross functional project teams during development, review and submission of regulatory dossiers
- Leading risk management activities
- Planning and monitoring of design verification activities
- Leading and authoring technical documentation
- Ensuring a high quality Design History File
- Supporting the improvement of the SaMD QMS

Requirements:

-MSc/MA in computer science or relevant field and excellent understanding of the current Agile development methods and technologies
-Experience in project/program management of complex projects
-Autonomous and independent working style with at least 7 years of experience as technical project management of projects with safety critical applications in a regulated environment
-Team player who works efficiently in interdisciplinary teams
-Experience in designing innovative software and systems architectures
-Analytical thinking and problem solving capability
-Excellent understanding of software design and programming principles as well as in overall verification strategies, including test set up and test automation
-Considerable experience of managing external suppliers
-In addition to outstanding project management and interpersonal skills, a strong background in software development and life cycle management, as well as the use and implementation of platform technologies, is crucial for this role.
- The successful candidate will play a critical role in the support and sustainable expansion of the SaMD area.

Contact: or call.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    01/10/2020

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Michael Bailey Associates - Munich