BD (Becton, Dickinson and Company) R&D Staff Engineer_R&D_上海 in Shanghai, China

Job Description 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.

Job Description

KEY RESPONSIBILITIES

Create/manage the product development plan and align with cross-function team Manage regular technical meeting with cross-function team Manage R&D Design History File Work with strategic/upstream marketing team to define the customer needs Work with RA/QA/MA/Marketing to define the design input, create the product spec Lead system architecture design, component design, material selection, tooling design and qualification, manufacturing transfer and process validation, part qualification Manage V&V plan creation, V&V testing with assigned extension team’s support Support marketing VOC activities Support CFDA product standard, type testing, dossier preparation, clinical trial Work with core team lead to manage the design review and project plan Quickly identify key project issue and effectively create of mitigation plans in a timely fashion. Coordinate cross functional team to resolve in field product issue, including customer complaints, root cause analysis and solution implementation. Supporting R&D Director to investigate early opportunities from the platform and project pipeline management Provide technical leadership and mentorship to the mechanical engineering team. 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

SKILLS

  • Excellent problem-solving skills

  • Excellent interpersonal communication skills – verbal/written in both Chinese and English

  • Have entrepreneurial spirit, full of accountability and passion

  • Good learning curve

  • Desire to drive accountability across project teams and functional team members.

  • Technical team leadership ability

Primary Work Location

CHN Shanghai - HQ

Additional Locations

CHN Suzhou Plant 1

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.