||Japanese leading manufacturer
|Candidate will work for Project Management department
-Lead cross functional project teams with assigned project, to develop medical device(Medical scope) according to defined project management planning;
-Define and manage schedule, design and development process, project expense, product cost, deliverable, etc., to meet customer’ requirements, Quality, Cost and Delivery targets.
-Manage overall project/technical risks and issues, interface with internal and external stakeholders.
-Ensure and drive effective communication with internal and external stakeholders;
-Regular reporting to Management on project progress and mitigation of project risks.
-Minimum 5 years’ experience in project or technical management position
-Knowledge of ISO13485 Quality Management System, ISO14971 Risk Management, and Medical Regulatory standards e.g. IEC60601-1, FDA, MDD etc.
-A team player with excellent communication, presentation and interpersonal skills.
-Have a positive work attitude and able to work in a fast-paced environment.
-Possess a high level of independence, confidence, initiative, integrity and resourcefulness.
-Proficient with MS Office applications with in-depth knowledge of MS Project, Excel, Word, Power Point, and other applications.
-Experience and knowledge related with medical devices