上海招聘

职位描述：

Responsibility：

This position is responsible for assessing the biocompatibility processes and related technical expertise in support of new product development for Bard Medical Device. Will assess material changes with an understanding of polymers in human and animal biological systems.

The ideal candidate must be able to work in a team oriented, fast paced environment.

？ Responsible for biocompatibility assurance including documentation, testing and inspection, product and process development, and non-conforming product investigations.

？ Will support New Product Development to ensure biocompatibility assessments are in compliance with all internal and external guidelines.

Requirements：

？ Assesses biocompatibility and aging test requirements for new products

？ Reviews material and toxicological assessments

？ Determines what biological and material testing is required

？ Develops biological and material test requirements to assure specifications & regulations are met

？ Analyzes design inputs

？ Prepares biocompatibility test requests and reports and reviews/approves protocols, reports and data

？ Coordinates laboratory studies pertaining to biocompatibility

？ Manages/reviews testing outlined in protocols and test methods and defines why acceptable

？ Interprets test results and makes recommendations as to the disposition of new processes, materials and/or vendors

？ Analyzes problems in design, process and test development. Recommend/implement solutions

？ Develops and implements procedures/policy

？ Provides timely information to product teams on material issues which will affect the new product development

？ Provides technical support on chemical components, material methods, systems and equipment

？ Maintains a professional working relationship with internal & external customer and support staff

？ Trains on, understands and follows company procedures and regulatory requirements

？ Interprets and acquires background information on materials where applicable

Qualification：

？ Education & Experience:

n Major in in Biomaterial, Chemical Engineering, Toxicology, Material Science, Microbiology or a closely related scientific discipline

n a Bachelor degree with 6 (six) years of related engineering experience within the medical device or equivalent regulated industry; or a Master degree with 5 (five) years of related engineering experience; or PhD with 4 (four) years of related engineering experience; PhD preferred

n The above experience must include 3 (three) years proven and effective project management skills from development cycle through manufacturing

n The incumbent must demonstrate the ability to perform the essential functions of the job as outlined in the duties and responsibilities

？ Knowledge/Skills:

n Requires experience in developing/supporting devices tested under ISO 10993 standards

n Knowledge of general medical device process technology

n Comprehensive understanding of GMP requirements

n Understand biological systems

n Ability to interpret, understand and respond to FDA, ISO and ASTM methods and regulations pertaining to biocompatibility

n Ability to understand toxicological assessments and data

n Understand and interpret MSDS sheet information

n Understand the biological implications of failed ISO test data

n Ability to collect and analyze data and derive conclusions

n Ability to make recommendations to reach a solution

n Strong interpersonal skills

n Multi-project management skills

n Excellent communication skill

n Decision Making & Problem Solving

？ Language:

n Good verbal and written in English

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1907年，巴德公司在美国新泽西州创建。一百多年来，巴德遵循着质量、诚信、服务和创新的价值观，向全世界的医疗机构和专业人员提供着优质的产品和服务。从弗雷导尿管到血管支架、扩张球囊，从高科技的肿瘤诊断治疗产品到外科疝修补网片，一代代巴德产品创造的经典传奇以及巴德员工提供的专业化服务，为巴德公司赢得了行业声誉，也造就了巴德这一百年品牌。

        2008年，巴德集团在北京成立了自己的外商独资公司——巴德医疗器械(北京)有限公司。巴德专业销售市场团队的建立，新产品的不断上市和对专业教育活动的投入，带来了2008-2010年销售50%以上的增长，一举成为行业内业绩增长最迅速的公司，由此确立了巴德中国的市场领导地位，使我们可以有机会服务于广大医生、护士及医疗机构，并造福于千千万万的中国患者。

    2010年上半年，巴德医疗科技(上海)有限公司和巴德中国医学科学中心（上海）相继成立，这是巴德公司在进入中国十余年后里程碑式的建设。同年7月，巴德医疗科技(上海)有限公司中国区运营中心在上海外高桥正式全面运行，为巴德产品的市场提供支持和保障。2011年巴德中国医学科学中心（北京）也将投入使用。 通过不断地研发与并购，巴德成功地实现百年成长，公司的销售和生产触及到世界的每一个角落，巴德在中国的投资发展更是体现巴德始终如一的市场战略。秉承着产品创新这一公司发展的重要驱动力，今天的巴德中国已建成五个产品分部（专业外科部、血管通道部、外州血管部、活检/常需医疗部、电生理部），上千种产品。巴德成立两个学术交流中心，拥有六个功能齐全、设施完备的区域办公室和一支400人、富有激情的专业市场销售精英团队，这些都更好地服务于中国广大病患和医务工作者。

    2011年，巴德中国公司的成长率继续领跑巴德全球各分公司和中国医疗器械行业。2011年底，巴德中国经销商销售管理系统全面上线，给所有部门提供了医院终端销售和代理商库存的全新视野。通过WAVE II招聘引进了大批优秀的人才，成为公司未来发展最有力的引擎和推动力。