FREELANCE: Lead Application Developer - Human Factors / SaMD
- Employer
- Umbilical Life
- Location
- Canton of Basel-Stadt (CH)
- Salary
- £Daily Rate
- Start date
- 24 Sep 2020
- Closing date
- 24 Oct 2020
View more
- Discipline
- Information Technology, Information Services, Programming, Project Management, IT Project Management
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
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
Company
Umbilical will be a world leading provider of workforce solutions in Science, Technology and Engineering.
Blending innovation and a commitment to entrepreneurship, we will ensure our customers and colleagues achieve the highest levels of satisfaction.
With nearly 75 years of workforce industry experience between us we know a lot, but not everything.
We have created a Mission, Vision and a set of clear Values, providing‘guiding light’ as we all start building this Culture, or as we call it the CODE.
- Website
- http://umbilical.co/
- Telephone
- 011 6 461 0070
- Location
-
Premier House
9 Rutland Street
Leicester
LE1 1RE
United Kingdom
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