Job Description 

Duties and Responsibilities:

•Implement the quality plan to ensure the quality of the products from the beginning of the product design circle to the end, which requires the effective and harmonious communication.

•Develop V&V strategy & test plan for medical product.

•Understand and comply with QMS of different organization per project needs, handle with internal and external audit on any Standard operation Procedure and other regulatory needs 

•Analyze customer's requirement and/or product usage environment conditions. 

•Review product design concepts and develop/modify activities plans

•Develop test hardware and software systems for testing of medical product modules. 

•Follow up and keep track of record about product/project life cycle. Comply with standard Operation Procedure 

•Perform analysis and teardown to investigate failures and list of potential design issues. 

•Planning and conduct new validation equipment assessment by working with other parties, include other parties within  Medtronic and out of company

•Co work with Quality Assurance team, Coordinate validation test facilities resources per product development requirement

•Supporting product development efforts by participating in the system architecture design process, contributes to the completion of quality plans, reviewing design plans, and ensuring appropriate control plans are provided for design transfer

•Ensure that the Project documentation is current and accurate.

•Attend the team meetings by preparing the agenda, project updates.

•Support, develop, and promote new technology and processes 

•Meet Departmental Quality Qualifications 

Job Qualification:

Education: 

•Bachelor or above in engineering or scientific discipline.(Computer Science, Software Engineering, Electronic Engineering, Automation Engineering, Biomedical Engineering, Mechanical Engineering, Optical Engineering .. etc.)

•PMP certificate holder is preferred

Experience:

•Bachelor’s plus a minimum of 5 years with system level testing and troubleshooting; electronics and software engineering experience in automatic test equipment development for medical device, automobile or aviation is preferred.

•Master degree with 3+ years of experience on medical product system level testing and troubleshooting is preferred.

•Solid experience of project testing lead with 3+ group members will be a plus

Skills/Competencies:

•Action Oriented

•Customer Focus (PDT, PLs, PMT)

•Listens & Communicates Effectively

•Problem Solving

•Creativity and proactive working attitude.

Specific Skills:

•Experience involving in technical projects with medical devices

•Excellent English and Mandarin Skills

•Familiar with Laparoscope products,  Endoscope products ot embedded system based medical devices is preferred.

•Familiar with ISO13485 and has experience on medical device product registration document preparation is preferred.