About the role
AI summarisedJunior systems engineer supporting Software as a Medical Device projects, working with project managers and cross-functional teams to ensure compliance with medical device lifecycle processes and ISO 13485 standards.
ResearchOnsiteDiagnostics Development Hub
Key Responsibilities
- Support project manager to plan and execute Software as a Medical Device (SaMD) projects including AI applied to healthcare
- Support technical team in product development, design verification and validation of medical devices including software as medical device
- Prepare, design and development documentation by working together with software developers, quality and regulatory personnel
- Prepare project agreements, procurement specifications and technical documents
Requirements
- Preferred to have one year of experience in software development or medical device product development
- Educational background of computer engineering or bio medical engineering
- Knowledge in software development, experience in software development environment will be an added advantage
- Knowledge / willingness to learn the ISO 13485 documentation practices and drive project teams for adherence
- Good follow up skills