R&D Engineer (Testing)-00000NVA
Description
Policies: Know & follow Johnson & Johnson policies & procedures related to work activities performed in area of responsibility.
Safety: Follow all company safety policies & other within work area. Promote safety to all associates that enter work area safety precautions.
Project: Apply knowledge of general engineering principles, materials, DFMA & reliability to achieve characterization needs, product design requirements and project deliverables. Work with customer, partner/sponsors/ stakeholders to identify characterization, opportunities, project scope and and evaluate potential technical solutions. Work within a cross functional project team to implement the project from initiation, technical transfer to launch, to assist in articulating technical aspects with broad project pictures.
Design Control:
- Prepare characterization Plan for assigned products / projects.
- Partner with affiliated disciplines to assure adequate inputs are included.
Validation:
- Organize the qualification and validation activities of appropriate and relevant equipment.
- Optimize product testing & release needs.
- Perform initial regulatory review for change control.
Technical:
- Project technical support to project team in characterization development, including but not limited to material choice, surgical procedures, formulation development and optimization, and material/formulation processing.
- Support risk assessment activities: FMEA (Failure Mode Evaluation & Analysis) & FTA (Fault Tree Analysis)
- Support review & report on analysis of field inquiry reports.
General:
- Assure consistency with China & corporate NPD governance Systems.
- Other responsibilities may be assigned & not all responsibilities listed may be assigned.
Others:
- Work Environment: Office environment.
- Travel Requirements: Extensive travel regionally and internationally. This assignment will be based in the China Innovation Center Suzhou facility.
- All employees are responsible for minimizing both the environmental and health and safety effects of the work that they perform.
Qualifications
- Must have bachelor's degree, nice to have Master degree.
- 2-4 years working experiences is a must, 5-7 years will be nice
- Bilingual: English/Mandarin required
- Advanced quality systems (AQS)
- Team interpersonal: partnering, interaction, feedback, negotiating, training.
- Effective team interpersonal skills and the ability to work effectively within diverse cultural environments.
- Reliability & quality engineering.
- Oral & written communication in Mandarin and English.
- Quality assertiveness.
- Self-managed—work with minimal supervision.
- Analytical & creative thinking.
- Project management—support multiple projects simultaneously.
- Problem-solving & priority setting.
- Organizational & integral—synthesize information from a variety of sources.
- Capable—understand new concepts quickly.
- Research—maintain on-going learning of industry, regulations.
- Knowledge of:
1. Regulatory compliance knowledge: GMP (Good Manufacturing Practices), MDD (Medical Devices Directive), 510K (Pre-market Notification).
2. Government, trade association, industry & medical publications.
3. Statistics
4. Product knowledge
5. Gage reliability & repeatability theory & application
- Computer Skills
1. Personal computer skills, Windows: word processing, project planning, presentation, e-mail & spreadsheet software.
2. Able to learn & apply software packages as required.
Primary Location:Asia Pacific-China-Jiangsu-Suzhou
Organization: Johnson & Johnson Medical Suzhou Ltd. (7054)
Travel:Yes, 10 % of the Time
Job Function: Biomedical Engineering
Description
Policies: Know & follow Johnson & Johnson policies & procedures related to work activities performed in area of responsibility.
Safety: Follow all company safety policies & other within work area. Promote safety to all associates that enter work area safety precautions.
Project: Apply knowledge of general engineering principles, materials, DFMA & reliability to achieve characterization needs, product design requirements and project deliverables. Work with customer, partner/sponsors/ stakeholders to identify characterization, opportunities, project scope and and evaluate potential technical solutions. Work within a cross functional project team to implement the project from initiation, technical transfer to launch, to assist in articulating technical aspects with broad project pictures.
Design Control:
- Prepare characterization Plan for assigned products / projects.
- Partner with affiliated disciplines to assure adequate inputs are included.
Validation:
- Organize the qualification and validation activities of appropriate and relevant equipment.
- Optimize product testing & release needs.
- Perform initial regulatory review for change control.
Technical:
- Project technical support to project team in characterization development, including but not limited to material choice, surgical procedures, formulation development and optimization, and material/formulation processing.
- Support risk assessment activities: FMEA (Failure Mode Evaluation & Analysis) & FTA (Fault Tree Analysis)
- Support review & report on analysis of field inquiry reports.
General:
- Assure consistency with China & corporate NPD governance Systems.
- Other responsibilities may be assigned & not all responsibilities listed may be assigned.
Others:
- Work Environment: Office environment.
- Travel Requirements: Extensive travel regionally and internationally. This assignment will be based in the China Innovation Center Suzhou facility.
- All employees are responsible for minimizing both the environmental and health and safety effects of the work that they perform.
Qualifications
- Must have bachelor's degree, nice to have Master degree.
- 2-4 years working experiences is a must, 5-7 years will be nice
- Bilingual: English/Mandarin required
- Advanced quality systems (AQS)
- Team interpersonal: partnering, interaction, feedback, negotiating, training.
- Effective team interpersonal skills and the ability to work effectively within diverse cultural environments.
- Reliability & quality engineering.
- Oral & written communication in Mandarin and English.
- Quality assertiveness.
- Self-managed—work with minimal supervision.
- Analytical & creative thinking.
- Project management—support multiple projects simultaneously.
- Problem-solving & priority setting.
- Organizational & integral—synthesize information from a variety of sources.
- Capable—understand new concepts quickly.
- Research—maintain on-going learning of industry, regulations.
- Knowledge of:
1. Regulatory compliance knowledge: GMP (Good Manufacturing Practices), MDD (Medical Devices Directive), 510K (Pre-market Notification).
2. Government, trade association, industry & medical publications.
3. Statistics
4. Product knowledge
5. Gage reliability & repeatability theory & application
- Computer Skills
1. Personal computer skills, Windows: word processing, project planning, presentation, e-mail & spreadsheet software.
2. Able to learn & apply software packages as required.
Primary Location:Asia Pacific-China-Jiangsu-Suzhou
Organization: Johnson & Johnson Medical Suzhou Ltd. (7054)
Travel:Yes, 10 % of the Time
Job Function: Biomedical Engineering