- Basic: Up to $4200
- 5 Working Day: Mon- Fri
- Office Hour: 8am - 5.30pm
- Location: Ang Mo Kio (Transport Allowance $70)
- AWS + VB + MNC Medical Industry
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.
Applicants who possess relevant experience for the above responsibilities are most welcome to apply. If you do not possess the above experience, your application will still be considered on individual merits and you may be contacted for other opportunities.
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**We regret to inform that only shortlisted candidates would be notified.
Gan Chen Yun
Registration Number: R23116696
EA Licence No.: 06C2859 (MCI Career Services Pte Ltd)
