At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

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• SECTION 1: JOB SUMMARY
• As local technical SME to provide technic support in J& J MedTech Surgery China for component suppliers development, production line transfer to meet quality, cost and delivery requirements.
• Lead local technical team and suppliers for component manufacturing prototyping, process development, test data analysis, process guidance, and delivers technical requirements for development of components in China.
• Determine tooling requirements to maintain component supply. partner with suppliers and supplier quality to improve supplier process capacity, supplier process capability, supplier process maintainability, component assembly capability, and component output performance.
• Produce component cost comparisons and analyze alternative manufacturing methods for cost improvement projects (CIP’s).
• Provide engineering support independently and/or leverage global engineering resources to local suppliers for component problem solving, process improvement. Ensures that the components made by suppliers comply with quality, cost and delivery requirements.
• Lead local engineering team to conduct assembly line transfer or equipment local manufacturing and qualification.
• Work with global cross-function teams in potential CIP project opportunity searching, support local sourcing in local supplier searching and qualification.
• Mentoring local GTO TS team members to improve/enhance technical capability.
• SECTION 2: DUTIES & RESPONSIBILITIES*
• In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• o Follow J& J procedure to complete/review component qualification documentations, complete component CIP projects with global engineering team and suppliers to deliver qualified components by supplier engineering/process capacity and process maintainability improvement.
• o Review and qualify supplier tooling/process design and component fabrication to maintain component supply.
• o Provide technical support for the approval/ validation of changes/ improvements in supplier processes
• o Provide technical support for the resolution of component quality issues
• o Potentially coordinate RMI/CAD/BOM actives
• o Produce component cost comparisons and analyze alternative manufacturing methods for cost improvement.
• o Sustain supply chain continuity by qualifying and validating supplier tooling as per component approval procedures.
• o Ensures closure to component non-conformance issues with timely corrective action submission and approval of suppliers control plans.
• o Supports supplier evaluations for major service/products issue as needed.
• o Review Equipment Requirements of new production line, provide optimization comments according to China laws and regulations.
• o Create master qualification plan for transferred production line, ensure all activities follow J& J procedures and stability of production will be met.
• o Provide and share technical experience and guidance to team members for team capability improvement.
• o Involved in local potential supplier selection and qualification activities, provide technical assessment and improvement plan.
• o Provide valuable information to global engineering team to support CIP opportunity searching.
• o Responsible for communicating business-related issues or opportunities to next management level
• o Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• o For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• o Performs other duties assigned as needed
• SECTION 3: EXPERIENCE AND EDUCATION*
• · A Minimum of B.S. Engineering degree, Master Engineering degree or Ph.D. Degree (Preferred).
• 10+ Years of experience in design and manufacturing in medical device industry.
• · Experience completing projects with suppliers to improve the technical capability, capacity, maintainability, and efficiency of metal, plastic and/or electronic part processes is desired.
• · Familiar with new product development process in medical device industry.
• · Proven track record of successful collaborating with global development team.
• SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
• · Fluent in English and Chinese is preferred.
• · GMP/ ISO13485 awareness required.
• · Skill set
• o Knowledge of component manufacturing processes (preferably plastic injection molding, metal machining, stamping, casting, welding and MIM), component design for manufacturability, or design requirement cascade for instrument manufacturability.
• o Knowledge of components manufacturing costs analysis.
• o Knowledge of assembly process design and equipment qualification.
• o Familiar with manufacturing process related documentation, such as PFD, PFMEA and PCP. Experience of DFM/DFA is needed.
• o Familiar with equipment qualification process, experienced in the detail activities (IQ/OQ/PQ, MSA, CSV and etc.).
• o Project management skill is preferred.
• o Statistical analysis skill is needed.
• o Experienced in supplier communication and assessment.
• o Mold design 3d software is preferred