EDUCATION / EXPERIENCE REQUIREMENTS:
• A baccalaureate degree in biomedical, electronic, computer science, or mechanical engineering is required. A master's degree in these fields is preferred; a PhD is a plus but not important. An ideal candidate would be a person with a degree in electrical engineering plus medical device practical experiences.
• Must have prior hands-on practical medical device Engineering experience, from products development to regulatory approval, to commercialization. Experience level would be anticipated to be 10-15 years of overall Engineering experience, with progressively responsible, professional and successful innovation as noted above.
• Successfully applying PPG and/or ECG/EKG technologies to develop products for vital sign measurements devices, and integrating wireless communication technologies and medical devices sciences for cloud patient monitoring would be required, prior practical experiences of developing and commercialization wearable ECG product would be a huge plus.
• Knowledges of medical device manufacturing processes and understanding GMP system, ISO 13485 and FDA regulations for the development of Medical Devices are important
• Concerning prior medical device experience, previous experience with market-leading, innovative long-term patient use, wearable products is expected. Prior direct experience in vital sign sensors and patient monitoring systems products is strongly preferred, but other innovative medical device Engineering leadership may be considered.
• General and business economics and administration, as well as the special techniques for the planning, direction, and control of scientific and technical work. Proven track record of attracting, developing, motivating, and retaining world-class R&D talent
• Demonstrated successful history of inspiring and visionary leadership to engineers and technical managers.
• Preparation, analysis, and interpretation of forecasts, technical feasibility studies, process and product evaluations, appropriations, and budgets.
• Office practices including full Microsoft Suite. Other areas of skill in engineering may include
• Basic research methods and elements of report writing; basic statistical methods and their uses.
具醫療器材產品研發10-15年以上實務經驗，熟悉TFDA 及 FDA醫療法規者。
具有ECG及 PPG 產品研發設計至審查認證及上市實際經驗者。