
Senior Product Development Engineer
2 weeks ago
**Responsibilities**:
- Writing or reviewing biocompatibility documentation.
- 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.
- Ad-hoc duties as assigned by Section Head.
**Job Requirement**:
- Degree in Biomedical/Material Science or relevant discipline.
- Minimum 2 years’ working experience in writing or reviewing biocompatibility documentation.
- Experienced in medical device field is preferred.
- Proficient in Microsoft Office.
- Data analysis skill.
- Able to work independently.
**Job Types**: Permanent, Full-time
Pay: $3,600.00 - $4,500.00 per month
Work Location: In person
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