Product Development Engineer
5 days ago
Product development of disposable medical devices.
- Plan and execute Product Development Activities.
- Pursue set & defined goals & targets.
- 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.
- 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 or relevant discipline.
- Minimum 2 years’ working experience.
- Experienced in medical device field is preferred.
- Proficient in Microsoft Office.
- Data analysis skill.
- Able to work independently.
- Team player.
**Job Types**: Full-time, Permanent
Pay: $3,550.00 - $3,800.00 per month
Schedule:
- Monday to Friday
Supplemental Pay:
- 13th month salary
- Performance bonus
**Education**:
- Bachelor's or equivalent (preferred)
Work Location: In person
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