(Sr. ) Design Engineer - R&D - Suzhou/ Shanghai
碧迪医疗器械(上海)有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2017-06-27
- 工作地点:苏州
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 语言要求:英语 熟练
- 职位类别:机械工程师
职位描述
职位描述:
GENERAL FUNCTION:
Reporting to R&D Associate Director, the associate’s main responsibilities include but not limited to leading or supporting new product development with a global team and/or providing sustaining engineering to existing products. Hands-on work on product requirement development, mechanical part design (Solidworks), testing method development, design verification and validation are expected. The associate may also support technology transfer, clinical trials, and product registration. Key skills includes mechanical design, problem-solving, innovative thinking, fluent communication in both English and Chinese, ability to work with a team, and etc.
RESPONSIBILITIES:
1. Serve as technical lead/project engineer for major new product development projects. Ensure that engineering design activities are coordinated per design control procedures.
2. Work closely with other functional areas (marketing, unit quality, and etc.) to deliver quality prototype or product designs.
3. Lead and/or support major design control related activities including design input, prototype building, design verification/validation, design transfer, and etc.
4. Lead and/or support project planning and provide technical team leadership in project execution.
5. Provide technical leadership and mentorship to the engineering team.
6. Research design options and perform feasibility evaluation on potential solutions.
7. Interact with global and internal design and manufacturing team to assess design for manufacturability, reliability and cost-effectiveness.
8. Review design control documents.
9. Evaluate product non-conformances and make recommendations on design modifications.
10. Work closely with regulatory and medical groups and provide technical support, testing support and dossier preparation for CFDA registration.
POSITION REQUIREMENTS (AS APPLICABLE):
EDUCATION:
Bachelor’s degree in industrial design engineering, mechanical engineering, or similar discipline required
Master degree in industrial design engineering, mechanical engineering, or similar discipline preferred
EXPERIENCE:
8 years related experience in a technical field
Experience in a cross-functional product development team required; medical device experience preferred.
SPECIAL SKILLS:
Excellent problem-solving skills
Excellent interpersonal communication skills
Must be familiar with CFDA requirements.
Previous experience in CFDA dossier preparation preferred
Exposure to high-volume manufacturing operation/processes desired
KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES:
? Bachelor’s degree in Industrial Design Engineering, Mechanical Engineering and 7-10 years’ experience in medical device mechanical design and manufacturing.
? Experience working in a cross-functional team.
? Experience with Solidworks.
? Experience with molded plastic part design.
? Experience with rapid prototype design and build for proof of concept and usability testing.
? Technical team leadership.
? Excellent interpersonal communication (English and Chinese, oral and written).
? Experience with Failure Mode & Effects Analysis (FMEA)
? Statistical techniques and/or Six Sigma methodology
举报
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GENERAL FUNCTION:
Reporting to R&D Associate Director, the associate’s main responsibilities include but not limited to leading or supporting new product development with a global team and/or providing sustaining engineering to existing products. Hands-on work on product requirement development, mechanical part design (Solidworks), testing method development, design verification and validation are expected. The associate may also support technology transfer, clinical trials, and product registration. Key skills includes mechanical design, problem-solving, innovative thinking, fluent communication in both English and Chinese, ability to work with a team, and etc.
RESPONSIBILITIES:
1. Serve as technical lead/project engineer for major new product development projects. Ensure that engineering design activities are coordinated per design control procedures.
2. Work closely with other functional areas (marketing, unit quality, and etc.) to deliver quality prototype or product designs.
3. Lead and/or support major design control related activities including design input, prototype building, design verification/validation, design transfer, and etc.
4. Lead and/or support project planning and provide technical team leadership in project execution.
5. Provide technical leadership and mentorship to the engineering team.
6. Research design options and perform feasibility evaluation on potential solutions.
7. Interact with global and internal design and manufacturing team to assess design for manufacturability, reliability and cost-effectiveness.
8. Review design control documents.
9. Evaluate product non-conformances and make recommendations on design modifications.
10. Work closely with regulatory and medical groups and provide technical support, testing support and dossier preparation for CFDA registration.
POSITION REQUIREMENTS (AS APPLICABLE):
EDUCATION:
Bachelor’s degree in industrial design engineering, mechanical engineering, or similar discipline required
Master degree in industrial design engineering, mechanical engineering, or similar discipline preferred
EXPERIENCE:
8 years related experience in a technical field
Experience in a cross-functional product development team required; medical device experience preferred.
SPECIAL SKILLS:
Excellent problem-solving skills
Excellent interpersonal communication skills
Must be familiar with CFDA requirements.
Previous experience in CFDA dossier preparation preferred
Exposure to high-volume manufacturing operation/processes desired
KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES:
? Bachelor’s degree in Industrial Design Engineering, Mechanical Engineering and 7-10 years’ experience in medical device mechanical design and manufacturing.
? Experience working in a cross-functional team.
? Experience with Solidworks.
? Experience with molded plastic part design.
? Experience with rapid prototype design and build for proof of concept and usability testing.
? Technical team leadership.
? Excellent interpersonal communication (English and Chinese, oral and written).
? Experience with Failure Mode & Effects Analysis (FMEA)
? Statistical techniques and/or Six Sigma methodology
职能类别: 机械工程师
公司介绍
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit ******.
关于BD
BD是一家全球化的医疗技术公司,通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD关注并支持每位一线医务工作者,致力于通过研发创新技术、服务和解决方案,帮助患者改善临床治疗,并帮助医护人员改进临床流程。BD及其65,000名全球员工秉承高度的热情和信念,致力于帮助提升患者的治疗效果,为临床医护人员提供安全、高效的护理给药流程,协助实验室科学家们更有效地诊断疾病,并提升科研人员研发新一代诊断及治疗疾病的能力。BD在几乎所有国家均设有分支机构,与全球范围内的组织机构积极合作,携手应对最具挑战的全球健康问题。通过与客户的紧密协作,BD以改善治疗结果,降低医疗成本,提升诊断效率为己任,帮助加强患者和医护人员的安全并扩大医疗可及性。2017年,BD欢迎巴德及其产品加入BD大家庭。更多信息,敬请访问**********/china。
关于BD
BD是一家全球化的医疗技术公司,通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD关注并支持每位一线医务工作者,致力于通过研发创新技术、服务和解决方案,帮助患者改善临床治疗,并帮助医护人员改进临床流程。BD及其65,000名全球员工秉承高度的热情和信念,致力于帮助提升患者的治疗效果,为临床医护人员提供安全、高效的护理给药流程,协助实验室科学家们更有效地诊断疾病,并提升科研人员研发新一代诊断及治疗疾病的能力。BD在几乎所有国家均设有分支机构,与全球范围内的组织机构积极合作,携手应对最具挑战的全球健康问题。通过与客户的紧密协作,BD以改善治疗结果,降低医疗成本,提升诊断效率为己任,帮助加强患者和医护人员的安全并扩大医疗可及性。2017年,BD欢迎巴德及其产品加入BD大家庭。更多信息,敬请访问**********/china。
联系方式
- Email:club@51job.com
- 公司地址:中国上海市浦东新区东育路221弄11号前滩世贸中心三期B栋12-18楼 (邮编:200040)