The candidate is required to:
- Evaluate, initiate and execute medical device product development projects of various developmental stages towards commercialization.
- Communicate regularly and effectively with researchers, clinicians and industry to conceptualize and design novel, clinically relevant and commercially viable medical device products.
- Design and plan experimental procedures in a certified Laboratory to integrate, test and validate novel medical products and systems according to recognized industry standards.
- Work in close partnership with the project team to define project plans and budgets, develop and maintain project timelines, establish and monitor project risks and risk register and lead the project teams to achieve project deliverables and objectives in accordance to ISO 13485.
- Lead the technical team in product development, verification and validation of medical devices including software as medical device, in vitro diagnostic assays and devices and etc.
- Write design optimization and verification plans and reports in accordance to ISO 13485 and other relevant standards such as IEC 62304, GLP, GCP etc.
- Work closely with quality assurance and regulatory affairs department on regulatory strategy planning and regulatory dossier preparation
- Review verification and validation protocols and reports
- PhD, MBBS or Masters degree in the Biomedical Science, biomedical engineering.
- At least 5 years of working experience preferably in the medtech, healthcare, or biomedical industry
- Knowledge and competence in intellectual property and patent portfolio management, and experience with innovation or product development or commercialisation processes would be advantageous