常熟招聘

Description

?     Usability Engineering Management within the Global Product Development Process for active and non-active medical devices.

?     Usability Lab.

Responsibilities

?     Support and manage, accomplish and document the Usability engineering process in conformance with the normative standards (e.g. ISO/IEC 62366, ISO 14971, ANSI/AAMI HE75).

1.    Coordination of all measures for compliance required by e.g. ISO/IEC 62366 requirements for usability-oriented development process and sustaining engineering (analysis, design, evaluation);

2.    Manage, monitor, assess and document the formative and summative evaluations, using appropriate methods and document accordingly;

3.    Organize recruitment of test participants, organize test environment and tools. 

?     Support and consult the Usability-Engineering & Requirement process in cooperation with stake holders.

1.    customer and user needs analysis, context analysis, workflow analysis.

?     Support and consult the process of generating product documentation & terminology.

?     Support and consult the generation of product specific documentation IFU / SM / Service Tools.

1.    Definition of product / system specific training content and training material.

?     Support the market preparation activities to enter the markets

1.    Competitor Analysis in terms of Usability Engineering and user context;

2.    Post market questionnaires.

?     Organization, coordination, support and maintenance of the usability lab with all the necessary accessories, video and audio technology for conducting usability assessments

Qualifications/Experience:

?     BA/BS in Biomedical Engineering and /or Usability/Human Factors Engineering and/or Industrial Design;

?     Good knowledge in Workflow and Process analysis;

?     Fluent written and spoken English;

?     Solid Knowledge in MS Office, Basic Knowledge in Electronic Data Management;

?     Willingness to travel (10-15%).

Knowledge/Skills/Abilities:

?     Knowledge in usability engineering management;

?     Experience in the medical device industry;

?     Experience of international regulatory and normative standards of medical device;

?     Good knowledge of Project Management methodologies tools and best practices;

?     Strong commitment and flexible organization of working time and environment;

?     Demonstrates initiative; results oriented; strong sense of urgency;

?     Strong analytical, planning, organization and time management skills;

?     Profound analytical skills and exceptional network thinking capability;

?     Intercultural experience and skills.

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