Opportunity to join clinical stage Medical Device organization developing life changing oncology products, where you'll have full autonomy over the software quality. Joining an software development,and quality team, you'll take the reigns as they look to bring their awesome technology to market!
- To guide the software quality through software design processes, performing clinical risk assessments, ensuring the compliance of documents under FDA 21 CFR 820, IEC 62304, ISO 14971, IEEE standards
- SME and owner of the Software Lifecycle Design SOP and ensure software elements are up-to-date within a QMS for a product that has multiple subsystems and components; disposables, reusable, hardware, and drug components.
- Provide strategic input to the Software Development team and assist fully with the execution of the Software V&V Test Plans
- Collaborate with the sustaining engineering team to investigate NCMRs, CAPAs, deviations, and complaints relating to software
- Bachelors degree in an Engineering discipline, preferably in Biomedical, Software, or Computer Engineering.
- Minimum 3 years of experience in the medical device field, including experience with the Software Lifecycle regulatory guidance
- Willingness to undertake learning Computer System Validation (CSV) and Computer Software Assurance (CSA) techniques.
- Experience utilizing Software Development tools and associated systems for requirements management preferred
- Familiarity with IEC 62304, ISO 14971, 21 CFR 820, ISO 13485, IEEE standards preferred
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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