**Job Description Summary**
Reporting to 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**
**GENERAL FUNCTION:**
Reporting to 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.
**RESPONSIBILITIES:**
Lead a global team on new product development and create/manage product development plan Manage regular technical meeting with cross-function teams Manage R&D Design History File Work with strategic marketing team to define customer requirements Work with RA/QA/MA/Marketing to develop product requirements 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 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.
**POSITION REQUIREMENTS (AS APPLICABLE):**
EDUCATION:
Bachelor or Master degree in mechanical engineering or similar discipline required
Ph.D degree in mechanical engineering or similar discipline preferred
LICENSES OR CERTIFICATIONS:
None required
EXPERIENCE:
10 years or above mechanical product design/development experience and at least 4years above in medical device industry 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.
Familiar with stack-up tolerance analysis, GD&T and how to use statistics tool-MiniTab
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 plastics molding and tooling design
Familiar with ISO13485 and CFDA regulation. Can independently create and manage DHF.
Experience working in global cross-functional product development teams.
SPECIAL 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
Familiar with SAP etc document control system and design change control
Previous experience on registration documentation preparation preferred
Experience in disposable medical device preferred
Exposure to high-volume manufacturing set up, operation/processes desirable
KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES:
+ Excellent understanding of China regulatory requirement
+ Quality Management System (QMS) and design control procedures
+ Design/Application Failure Mode & Effects Analysis (FMEA)
+ Project management Process
+ Process Validation
+ Statistical Techniques and/or Six Sigma methodology (ex: DMAIC)
+ Patents & Trademarks
+ External Regulations (ISO, FDA, OSHA, ASTM)
COMPLEXITY OF DUTIES:
As defined in responsibilities section
**ACCOUNTIBILITY:**
IS THIS A SUPERVISORY POSITION?
YES
X
NO
IF **YES** , NUMBER OF INDIVIDUALS SUPERVISED?
DEPARTMENT TO WHICH THIS POSITION REPORTS:
R&D
IS THIS POSITION RESPONSIBLE FOR A BUDGET?
YES
X
NO
IF **YES** , HOW MUCH IS THE BUDGET?
IS THIS POSITION RESPONSIBLE FOR POLICY IMPLEMENTATION?
YES
NO
X
IF **YES** , WHAT TYPE OF POLICIES?
**Primary Work Location**
CHN Shanghai - JingAn Kerry Centre
**Additional Locations**
CHN Suzhou - Jiangsu Province (Zone 2)
**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.