Lead Expert App Development

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Beschreibung

Lead Expert App Development

The successful candidate is a recognized expert for 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 within the client Packaging & Device Development Team.

Tasks and responsibilities will typically include:
* 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,
* General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements,
* Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation), including those related to medical software (IEC 62304),
* Development and writing of technical documentation of drug/device combination products and medical devices, including the design control process and other applicable regulatory, QA and GMP aspects,
* Understanding of pharmaceutical development in general,

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start
06/2020
Dauer
12 Months
Von
Michael Bailey Associates
Eingestellt
03.06.2020
Projekt-ID:
1933284
Vertragsart
Freiberuflich
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