莆田招聘

POSITION SUMMARY（职位概述）

This position will join a dynamic R&D organization based in Shanghai that designs and develop medical devices for China. The successful candidate will lead R&D engineers/cross-functional project teams to execute medical device design and development work that meets regulatory and quality requirements while collaborating closely with other cross-functional leaders. The desired candidate will have leadership skills and a strong focus on meeting internal and external customer needs.

KEY RESPONSIBILITIES（主要职责）

1. Leader for product development project

• Generate product development plan/strategy
• Lead or support market research and acquisition of voice of the customer
• Lead translation of customer/market requirements into technical specifications
• Generate product/ subsystem concepts/designs that meet requirements
• Demonstrate proof of concept in the early phase
• Plan and execute on required feasibility testing to freeze product design
• Plan and perform on design verification
• Support design validation work
• Work with cross-functional team members on design transfer, production ramp-up, and product registration en route to product launch
• Generate documentation required per design control and regulatory requirements
• Support design transfer and production scale-up

SKILLS AND ABILITIES（技能）

1. A Bachelor degree in science or engineering with 8 (eight) years or a Masters degree in science or engineering with 5 (years) of engineering experience within the medical device or equivalent industry;

2. The above experience must include demonstrated practical problem solving, savvy communication, and project management skills.

3. The incumbent must demonstrate the ability to perform the job's essential functions as outlined in the duties and responsibilities.

4. Demonstrates analytical thinking and problem-solving skills

5. Able to foster teamwork

6. Capable of persuasive communication in spoken and written English and Chinese

7. Strong project management, planning, prioritizing, and multi-tasking skills to work within tight deadlines

8. Possesses good technical and functional skills such as:

• Understanding of design control (21 CFR 820.30)
• Create & critique engineering cost analysis;
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• l Working knowledge of 3D CAD software (e.g., Solidworks, ProE)
• Basic tooling design and drafting knowledge
• Design For Six Sigma experience or have a good understanding of inferential statistics;
• Proven product design & prototyping (e.g., invention patents)
• Knowledge of polymers (especially those commonly used in medical devices);
• Bioengineering principles;

9. Has good learning agility

DESIRABLE（优先条件）

1. A Ph.D. in science or engineering with at least three years of engineering experience

2. Understanding of regulatory environment for Medical Devices; experience with ISO requirements and GMP guidelines, FDA/NMPA regulations, medical device design control, and manufacturing scale-up processes a plus.

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。