长沙招聘

POSITION SUMMARY

Reporting to the R&D Associate Director, the associate manages all aspects of product development from concept through product launch, and shall create/manage the design and V&V plan tactically, who also needs to work closely with cross-function team to define customer needs, support line set up, regulatory submission/clinical trial and commercialization. As key technical lead, he/she also needs to guide other design engineers.

KEY RESPONSIBILITIES

1. Create/manage the product development plan and align with cross-function team
2. Manage regular technical meeting with cross-function team
3. Manage R&D Design History File
4. Work with strategic/upstream marketing team to define the customer needs
5. Work with RA/QA/MA/Marketing to define the design input, create the product spec
6. Lead system architecture design, component design, material selection, tooling design and qualification, manufacturing transfer and process validation, part qualification
7. Manage V&V plan creation, V&V testing with assigned extension team’s support
8. Support marketing VOC activities
9. Support CFDA product standard, type testing, dossier preparation, clinical trial
10. Work with core team lead to manage the design review and project plan
11. Quickly identify key project issue and effectively create of mitigation plans in a timely fashion.
12. Coordinate cross functional team to resolve in field product issue, including customer complaints, root cause analysis and solution implementation.
13. Supporting R&D Director to investigate early opportunities from the platform and project pipeline management
14. Provide technical leadership and mentorship to the mechanical engineering team.
15. Ensure compliance with local BD quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in mechanical engineering or similar discipline required

• Master or Ph.D degree in mechanical engineering or similar discipline preferred
• 10 years above mechanical product design/development experience and at least 4years above in medical device industry is preferred.
• Experience working in global cross-functional product development teams and product commercialization under design control required; in the area of medical devices preferred.
• At least one solid product launch experience is must from beginning to launch.
• Expert with Solidworks etc mechanical design tool, familiar with packaging/labeling design, Industry design experience is preferred
• Familiar with stack-up tolerance analysis, GD&T and how to use statistics tool-MiniTab
• Statistical Techniques and/or Six Sigma methodology (e.g. DMAIC)
• Familiar with V&V testing, testing fixture and manufacturing fixture development
• Skill in polymer material selection and validation, such as biocompatibility and aging testing
• Familiar with injection molding, extrusion, die cut etc manufacturing process and tooling design and qualification. Exposure to high-volume manufacturing operation/processes preferred

• Familiar with ISO13485 and CFDA regulation. Can independently create and manage the DHF.
• Previous experience writing documents such as CFDA dossier preferred

• Experience with rapid prototype design and build for proof of concept and usability testing.
• Design/Application Failure Mode & Effects Analysis (FMEA)

• Microsoft Project & project planning
• Familiar with Agile/SAP etc document control system and design change control

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。