北京招聘

Description

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

• Usability Lab maintenance.

Responsibilities

• Conduct and consult the Requirement and Usability Engineering process in cooperation with stake holders.

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

   2． Competitor Analysis in terms of Usability Engineering and user context.

• Support, manage, accomplish, and document UI Design requirement and Usability engineering process in conformance with the normative standards.

1. Coordination of all measures for compliance required by e.g. ISO/IEC 62366 requirements for usability-oriented development process and sustaining engineering.

2. Deliver design requirements and interaction prototypes.

3. Support and consult the process of generating product documentation & terminology of product specific documentation IFU and UI.

• Manage, assess and document the formative and summative evaluations.

1. Prepare the evaluation with plan documented.

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

   3.  Analysis and document the evaluation results.

• Support the activities after medical devices entering the markets.

1. Post market visits with questionnaires.

2. Supporting complaint analysis.

• Coordinate and maintain the usability lab with all medical devices, and tools for usability research (e.g.: video and audio) for conducting usability assessments.

• Organize storage and order of all the necessary device and accessories.

Qualifications/Experience:

• Master’s degree of Human Factors Engineering, or master’s degree of Biomedical Engineering, Industrial Design, Psychology, or other relative major, with 2+ year experience in Human Factors Engineering in Medical device industry.

• Bachelor’s degree with 2+ year working experience in Medical device industry; or bachelor’s degree of Nursing with 5+ year experience as a certified renal nurse, experience with medical devices in renal replacement therapy / extracorporeal therapies, detailed special knowledge & experience in the clinical environment.

• Experience in workflow and process analysis.

• Fluent spoken Mandarins and English.

• Good English technical writing skills.

• Quick learner and self-motivated.

• Proactive and demonstrative ability to work in a team.

• Willingness to travel (10-15%).

Knowledge/Skills/Abilities:

• Experience of human factors/usability engineering in medical device industry.

• Knowledge of international regulatory and normative standards of medical device e.g. ISO/IEC 62366, ISO 14971, ANSI/AAMI HE75.

• Good knowledge of Project Management methodologies tools with best practices. 

• Strong commitment, demonstrates initiative, results oriented.

• Multi-tasks handling, planning, organization and time management skills.

• Strong analytical thinking and design thinking.

• Flexible organization of working time and environment.

• Exceptional network capability, team worker, Intercultural experience and communication skills.

费森尤斯集团（德国）是一家全球性的医疗保健服务公司,以优质的医疗产品和可信赖的治疗服务享誉全球，是世界五百强企业之一。费森尤斯集团由位于全球范围内的四个独立的事业部组成，包括费森尤斯医疗用品、费森尤斯卡比、费森尤斯赫里奥斯、费森尤斯奥美德。
江苏费森尤斯医药用品有限公司（以下简称“费森尤斯常熟工厂”）隶属于费森尤斯医疗用品，公司成立于2007年7月，是一家集研发和生产功能于一体的企业。公司主要生产用于血液透析的配套产品。现我公司诚邀勤奋敬业、不断超越自我的专业人才加入费森尤斯大家庭！
费森尤斯常熟工厂能为在职员工提供良好的培训与无限的发展空间，同时您也可以在日常工作中领略到多国文化和谐交融的氛围，提高自己的口语水平并拓宽国际视野。另外，公司还为员工提供免费工作餐及常熟市内／苏州班车、年底绩效奖金、带薪年假及其他欧美独资企业所能享有的待遇