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。
•10 or more years of hands-on and successful experiences as a General Manager in advanced medical device companies
• Build a world-class Medical Device organization to drive the strategies and initiatives with the regulated medical device business in Taiwan
• Manage the business team to develop the Aulisa wireless continuous patient vital sign monitoring systems that meet FDA regulations and market clearance submission standards
• Responsible for all business functional areas in a complete Medical Device company in Taiwan, including R&D (product development), Marketing and Sales, Regulatory Affair including regulatory submission for FDA 510(K) and Taiwan TFDA product registration, CE Mark and 13485-2016 certification, medical device regulatory compliance; ERP implementation, supply chain management, GMP and Quality Systems
• Manage Marketing and Sales Team and implement new medical device product launches in Taiwan
• Drive annual revenue growth via a distributor or direct sales organization. Secure, retain and grow both new and existing accounts
• Execute plans for an IPO initiative to list Taiwan Aulisa’s stock in Taiwan Security Exchange in 2019
• Manage a GMP factory in Taiwan to manufacture all the Aulisa products to support the world-wide markets
• Maintain financials, in accordance with the Company’s governance and go, including the Annual Budget, P&L and Sales Forecasts.
• Other related duties and responsibilities as may be directed.
• Willingness to travel domestically and internationally as required