• Leading and managing the ideation, development and evolution of the product and new medical technology devices. • Advising on engineering and technical matters.• Leading and managing the company’s development team and working with external partners and resources.• Overseeing the operational policies and procedures for the startup company, including initiation and establishment of medical device quality management system.• Partnering with Chief Marketing Officer to drive the development of the clinical plan, clinical investigation protocol and other relevant clinical study documents to bring product through clinical phase.• Managing the technical documentation of the company and products and providing technical support in relation to any intellectual property rights and the obtaining of all relevant governmental approvals.

Medical Device Product Development• Developed, executed project plan to successfully meet deliverables and milestones on time for an electromechanical surgical device..• Experienced in implementing design and development control processes in a team to meet ISO13485 and Quality System Regulation requirements. • Established and managed technical file and documentation control.• Directly involved in R&D activities of new device, including development of test plans, establishing models, conducting testing, analyzing data with statistics and reporting.• Implemented risk management process (ISO14971) and performed hazard analyses, DFMEA and risk-benefit analyses.• Performed design verification and validation, including human cadaveric test, to ensure product meets design requirements, intended use and user needs.• Sourcing, evaluating and managing external suppliers based on capabilities and qualification.• Liaised with external laboratories in establishing test protocols and fulfilling regulatory requirements for entering into human trials. These include biological evaluation and biocompatibility study, electrical safety and electromagnetic compatibility, sterilization process and sterility testing. • Involved in clinical evaluation of new product and worked closely with clinical research organization to develop clinical plans and protocols for human trials.• Liaised with consultants in preparing and submitting for FDA Pre-submission to get technical feedback on pre-clinical and clinical testing of new device to work towards meeting US regulatory requirements.

Development of novel ear implants for patient treatment of ear diseases• Worked in a team consisting of various functions to successfully produce high quality version of grommet implants.• Performed in vitro characterization and anti-bacterial study of the implants.• Conduct in vivo implantation study in small animals, routine monitoring of animals and examination of hearing sensitivity of animals and implant performance.• Demonstrated promising research outcome with peer-reviewed medical journal publication.• Presented research work at international conference.• Managed office action of patent and maintenance throughout the project duration alongside patent office.• Developed research & business plans for fund raising activities. Development of novel active surgical devices• Worked in a team consisting of various functions to design and develop a mechatronic device for safe and quick deployment of ear implant.• Developed embedded prototype using Arduino programming and toolkit.• Experienced in breadboard and PCB prototyping using Altium Designer and Eagle.• Liaised and managed various external suppliers in outsourced activities.• Coordinated various stages of pre-clinical testing including animal and human cadaveric tests.• Responsible for establishing and managing documentation system. • Presented at international conference and conducted surveys to gain interest of physician in using the new product• Involved in grant and business proposal writing to secure funding to bring the device towards clinical trial and commercialization.• Mentoring and providing guidance to junior staff and internship student on mini projects.

Development of bioresorbable grommets as ear implants for treatment of ear infection• Successfully research and produce working grommet implants.• Performed microsurgery for implantation in animal models to test the performance of the prototypes.• Demonstrated promising research outcome from various pre-clinical tests.• Developed and filed new patent. Development of novel grommet tube delivery system for otitis media with effusion• Performed research grant writing and successfully secured funding.• Collaborated with engineering team to research ideas and brainstorm design of a proof-of-concept surgical device for safe and quick deployment of ear implants.• Successfully developed working prototype and filed patent.• Coordinated pre-clinical testing activities and managed the project to meet milestones on time.

Investigation of a novel biodegradable copolymer for sustained and controlled drug delivery for cancer treatment• Engineered drug encapsulated and protein-coated nanoparticles for targeted drug delivery.• Evaluated drug release and cytotoxic effect of nanoparticles to determine their performance and sustainability.• Performed pharmacokinetics and biodistribution analysis in Sprague Dawley rats and xenograf model.• Involved in undergraduate lab modules teaching and final year project supervising.