Product Support Engineer产品支持工程师

1.Support product transfer within pilot/ramp-up or mass-production sites by completing relevant PS activities

2.Perform design verification and report, provide internal training of product, material and end-user knowledge

3.Cooperate with relevant RA and QA to ensure design control and product meet the quality and regulation standard

4.Apply risk management and support on maintain risk management files

5.Give input to PMS (post-market surveillance) reports and participate in Product Review meetings if relevant

6.Create and maintain specifications, product description and composition (PDC) documents

7.Handle relevant activities in Change Control and update Manufacturing Flow Chart

8.Approve stability, transportation studies/reports and product drawings

9.Contribute to DHF/DMR and project documentation with essential PS knowledge

10.Analyse product performance (against intended use) and conduct comparison tests against competitors’ products

Qualifications

1.Bachelor’s degree in relevant technical background, e.g. Engineering, Pharmaceutical or Life Science (organic Chemistry or

applied chemistry is preferred)

2.At least 3 years of technical support experience or equivalent experience in relevant R&D, Quality or RA function

3.Good knowledge of legislation, system, and procedures applicable to the medical device industry

4.Basic data processing, statistical and analytical skills

5.Be familiar with MS Office / Lotus Notes or equivalent / Veeva or other e-documentation system

6.Experience with the medical device/life science industry in an international company is preferred

7.Be proficient in English, both verbal and written