工作內容

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. 

國內外醫學、生醫、機械、電機、電子等相關系所畢業。 

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。 

具醫療器材新創公司之市場評估與營運輔導經驗者。 

具有ECG及 PPG 產品研發設計至審查認證及上市實際經驗者。 

熟悉品質管理系統(ISO13485),具有電子產品、通訊技術整合之經驗能力者。 

 

工作制度/性質

工作地點:
台北市 南港區 園區街3之2號10樓    [地圖]
工作時間:
日班 說明:9:00~18:00
休假制度:
週休二日
工作待遇:
面議(經常性薪資4萬/月含以上)    [$薪資公秤]
工作福利:
[同公司福利]
公司福利 ×

法定項目
勞保、健保、週休二日

福利制度
獎 金 類:年終獎金、三節獎金
餐 飲 類:伙食津貼
娛 樂 類:員工聚餐、尾牙
其 他:員工在職教育訓練
*薪酬制度
依個人績效表現年度調薪
*假勤制度
同仁享有彈性上下班制度
*保險制度
海外旅遊平安險 : 同仁因公出差至海外期間,提供海外旅遊平安險
*福利制度
國內外參展機會
全自動義式濃縮咖啡機、咖啡、茶、零食


工作性質:
全職
職務類別:
機械工程主管 通訊工程研發主管 生技主管

其它說明:
需出差

要求條件

身份類別:
不拘
工作經驗:
15年以上工作經驗
學歷限制:
大學以上
科系限制:
機械工程學類 生醫工程學類 電機工程學類 電子工程學類 醫學學類

語言能力:
英文 聽-精通 | 說-精通 | 讀-精通 | 寫-精通
中文 聽-精通 | 說-精通 | 讀-精通 | 寫-精通
駕照車輛:
普通小型車
駕照   

附加條件:

• Experience and knowledge in working with international regulatory requirements and policies, such as ISO certifications, CE Mark, CFDA regulations 

• Excellent communication skills, to include verbal, written and presentation skills 

• Excellent medical acumen 

• Knowledge of financial principles and demonstrated experience managing department budgets 

profile
聯絡人員:
徐小姐

需求人數:
不限
到職日期:
不限

面試地址:
郵寄地址:
傳真號碼:

電子信箱:

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