Technical Lead - Software as Medical Device

Industriebereich:
Pharma
Currency:
£
Ort:
Schweiz
Gehaltsbeschreibung:
Negotaible
Veröffentlicht:
06/06/2019
Stellenreferenz:
123765

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 within the Packaging & Device Development Team.

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 methodsand 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)

Kontact: or call +41 (0) 44 215 2051

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

Kontaktangaben:
Telefon: 020 7739 2022
Kontakt: Luchele Valentina Mendes
E-Mail:

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