POSITION SUMMARY

Working closely with a dedicated global cross-functional project team, the candidate will support product development deliverables such as design verification and product registration. The candidate must have an understanding of design control and must follow BD Quality systems and comply with all regulatory and safety guidelines. Competent with Design of Experiments, Design for Six Sigma and Design for Manufacturability, the candidate is expected to be capable of working with complex mechanical systems and perform highly technical mechanical tests which may involve the use of tensile testers, fatigue cyclers, analytical impact equipment, vibration systems, life testing equipment, material testing, and various environmental testers (UV, ozone, and thermal) to establish dependable conclusions with sound statistical analysis. This position will report to R&D Associate Director.

KEY RESPONSIBILITIES

• Apply existing methods and develop new methods for the scientific analysis of medical device products’ functional characteristics, with a clear understanding of regulatory requirements for both drug and medical devices in China; supporting registration activities and issue resolutions.

• Apply Design to Cost and Design for Manufacturability methods to support project leader in achievement of project objectives.

• Provide expert engineering skill in design, functional performance and testing related to mechanical and physical properties.

• Understand and be proficient in specific mechanical requirements for pharmaceutical packaging materials/components/assemblies. Develop, write and verify test procedures as needed.

• Perform technical and quality risk assessments; support engineering studies, Design Verification and process validation activities in manufacturing (IQ/OQ/PQ).

• Collect and organize test samples, prepare test set-ups, study and perform tests according to testing requirements. Document all results accurately, complete in-depth statistical analysis and generate timely reports.

• Set up SOP, test samples and troubleshooting for type testing capability both internally and at 3rd labs when necessary.

• Evaluate and assess competitive products, processes or new trends.

• Maintain an overview of relevant technologies and products. Advise management of technology trends and risks.

• Design fixtures, tooling or experimental parts to meet special testing needs.

• Ensure protocol compliance/adherence to China national standards, e.g. NMPA, GB/T, YY/T, ISO and ICH standards, pharmacopeia monographs, Quality System per ISO 13485, etc.

• Monitor protocol execution end-to-end and ensure appropriate reporting, using available electronic database where applicable, e.g. BDM-PS Analytical Study Database.

• Ensure the lab in compliance with appropriate quality systems required by BD policies and its served markets (cGMP, GLP, etc.). Authoring lab procedures as necessary to remain in compliance with customer requirements

• Participate in identifying/defining needs for new mechanical methods and/or adaptation and translation of existing ones in order to propose state-of-the-art protocols.

• Perform other duties as assigned by Management.

• Responsible for following all safety processes and procedures.

• Provide technical support to Unit Business and customers as requested.

REQUIRED SKILLS AND ABILITIES

• Minimal Master of Engineering or equivalent in mechanical, biomedical, chemical or materials engineering or related field. Ph.D is preferred.

• 5-10 years of professional experience in mechanical engineering/design/testing in medical device or related industry.

• Strong technical skills and solid understanding of mechanical engineering knowledge.

• Skilled in CAD tools including SolidWorks or ProE, etc.

• Proficient in using statistical tools such as MiniTab, Excel, etc. for DOE and scientific data analysis.

• Excellent documentation skill to generate protocols and reports.

• Previous experience in using mechanical/materials testers highly desired.

• Must be dexterous, able to operate various equipment and use different metrology tools with hands-on experience.

• Familiar with regulatory requirements for medical device and drug packaging materials (China, EU/US).

• Fluent in English and Chinese, both oral and written.

• Excellent interpersonal, communication, and influencing skills.

DESIRABLE

• Experience in pharma registration is highly desirable.

• Ph.D is desired.

• DFSS experience and six sigma license(s) is a plus.

上班地址：工业园区白榆路5号

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 bd.com.

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www.bd.com/china。