Beschreibung
Human Factors/Software as a Medical Device - SaMD
#15578 | 12 month+ contract | Switzerland
James Carrera at Umbilical has partnered with a Global Pharmaceutical client to source an Expert Application Developer to support the expansion of SaMD, acting as technical leader for software development in Medical Device Development.
Accountable for:
Technical leadership for the software development of mobile and/or web applications classified as Software as a Medical Device (SaMD), providing software/systems life cycle expertise within a broader cross-functional drug product development team, as well as;
- Supporting the standardization of the entire SaMD life cycle management process to utilize cross-product synergies,
- Collaboration with external development partners: Selection and vendor management
- Leading/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.
Qualifications:
Educated to MSc/MA in computer science or relevant field and excellent understanding of the current Agile development methods and technologies, as well as;
- 7 years of experience as technical, project manager of projects with safety critical applications in a regulated environment,
- Designing innovative software and systems architectures, software design and programming principles, overall verification strategies, including test set-up & automation
- Fluency in English & German language incl. technical writing Experience desired,
- Human Factors Engineering, risk management/clinical studies
- 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)
- Technical documentation of drug/device combination products and devices, design control process and other applicable regulatory, QA and GMP aspects
For a confidential discussion, contact James Carrera at Umbilical
Reference ID: 15578
Contract length: 12 months
Job Types: Full-time, Contract