Japanese MNC located at Ang Mo Kio is currently looking for qualified individual to join their team.
JOB RESPONSIBILITIES:
- Plan, lead, coordinate and execute product development activities in blood management products, such blood bag products.
- Pursue set & defined goals & targets.
- Identify scope, application, projected market potential and price target.
- Define project approach & strategy.
- Identify critical success factors as benchmarks & constrains to overcome.
- Project budgeting & control.
- Manage and co-ordinate design projects with various departments, customers and supplier.
- Managing project schedule & timeline.
- Perform biological assessment to support material changes.
- Provide regular update to management on progress of projects.
- Preparation of Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER).
- Design, review and implement biocompatibility evaluations including biological testing, chemical characterization and Biological Risk Assessments (BRA) to comply ISO 10993.
- Biocompatibility sections in regulatory submission (Technical files, Design dossier, Clinical Evaluation Report (CERs).
- Maintaining up-to-date product standards compliance, technical file & design history file.
- Establish and carry out design verification test (Type Testing, Biocompatibility, etc).
- Perform designated equipment calibration and maintenance.
- Establish new SOP for test methodology.
- Ad-hoc duties as assigned by Section Head.
Job Requirement:
- Degree in Biomedical/Material Science/Life-Science/Manufacturing or relevant discipline.
- Minimum 2 years’ working experience in design and development of medical devices or blood component processing in a blood bank establishment will be preferred.
- Proficient in Microsoft Office.
- Data analysis skill.
- Able to work independently.
