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Location: Suzhou
Salary: salary negotiable
Industry: Life Science
Function: Engineering

Company Overview

公司2023年计划在中国扩大规模,重视员工的职业发展

Job Description

Qualifications:
• Have more than 5 years of practical experience of NPI or R & D and technical related in class II or III
medical device manufacturing enterprises medical device industry;
• Have a bachelor degree or above, major in electrical engineering or automation;
• Fluent oral English, also solid reading and writing skills in technical;
• With successful experience about new product introduced in medical device industry, active medical device
is preferred;
• With experience about verification and validation of design and development;
• With experience about setting Work Instructions and production process improvement;
• Good organization, communication and coordination skills; No record of violation of discipline or law;
• Independent and structured way of working;
• Assertiveness and organizational skills;
• Economical thinking and acting.

Responsibilities:
• NPI Document Development
Management of specification documents on technical and compliance with these specifications
Preparation of training materials
Participation in internal and external audits
• Qualification / Validation
Creating and maintaining the Qualification/Validation Master Plan
Supporting the creation of User Requirements Specifications and Design Specifications
Carrying out risk analyses (FMEA) in the Trial production of new products
• Process Management
Planning, coordinating and monitoring all production process and technical measures
Develop reasonable product process documents, be responsible for process parameters to ensure the rationality
of parameters, make a good document guarantee for subsequent mass production
Deal with quality problems in the first batch of mass production, provide feasible improvement plans
Responsible for after mass production on-site process and conduct to continuously optimize the process flow
• Continuous improvement
Identification of improvement potential on existing products and processes
Planning, coordinating and monitoring improvement measures