Job Description
Job Description:
ROLES & RESPONSIBILITIES
- Lead the design and development of new products and support design control, risk management activities
- Design and Develop image analysis software
- Analyse image analysis data and correlate them to clinical relevance
- Optimise software parameters and algorithms to correlate data analysis results with clinical relevance
- Manage the device development timeline
- Prepare and document Software as a Medical Device design and development documentation as per Quality Management System (QMS) requirements
- Support and facilitate ISO 13485 certification related activities
- Support and facilitate product regulatory submission to FDA, EU MDR and HSA.
REQUIREMENTS
- Bachelor's degree in computer science/electrical engineering/related discipline
- Previously developed a software application/ device (good to have)
- Experience ...
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