Lead Expert App Development

Beschreibung

Software as Medical Device - 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.

The role includes early phase development activities, the management and monitoring of software development at their external partners, and the commercialization and maintenance of overall life cycle management as legal manufacturer.

Tasks and responsibilities:

* 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,

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,
* Experience in designing innovative software and systems architectures,
* Excellent understanding of software design and programming principles as well as in overall verification strategies, including test set?up and test automation,
* 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,
Must have and highlight of the profile: Experience in Medical Device Development Project

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