- Singapore Singapore

工作地点
职位描述
岗位职责
Job Description:
· 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.
· Team player.
Job Types: Full-time, Permanent
Pay: $3,550.00 - $4,500.00 per month
Work Location: In person
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