Total 1 product specialist job vacancies in Engineering category in D03 Queenstown, Tiong Bahru

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.