The organisation is developing a revolutionary new NGS-based diagnostic platform in an easy to use, cartridge-based system designed to generate a clinically actionable result direct from clinical specimen, in a matter of hours. Their R&D department is expanding and now they have a vacancy for a Bioinformatics Software Documentation Specialist.
The objective for the ideal candidate is for them to guarantee compliance of DNAe BioInformatics pipelines and processes to the following standards: ISO13845, IEC62304, IEC 62366 standards. Your main responsibilities within this role will include:
- Actively contributing to the Documentation of the bioinformatics pipeline component
- Documentation of procedures and process configurations.
- Train Internal users to Bioinformatics SOPs, from using autonomously the BioInformatics pipeline to data management
- Compliance reviews
- Participate in relevant regulatory forums
As the ideal candidate you will have MS or PhD in Computer Science, Physics, Mathematics, or equivalently technical discipline, or extensive software product development experience. You will be Confident in windows and Linux environments, Git source code repository, Jenkins. You will have experience producing BioInformatics/software documents for regulated environments. Experience of the process requirements, documentation and traceability needed for regulated development. Experience developing medical software validation procedures.
Graduates with 1-2 years' experience also accepted, as training can be provided.
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