- Own the R&D project vision, communicate efficiently with data scientists or cross departments.
- Manage life-cycle algorithm development with full traceability:
- Literature research and proof of concept
- Indication of use, requirements and specifications
- Risks, hazards and mitigations
- Verification & validation and anomalies report
- Design reviews, documents control, and issue tracker
- Characterize algorithm performance on FDA guidelines or regulations if necessary.
- Documentation which clearly explains how algorithms have been implemented, verified and validated.
Interested candidate, please submit your updated resume in MS WORD format to:
- Minimum Master's Degree or PhD in Computer Science/Electronic Engineering/Biomedical Engineering/Statistics or related program with good experience in medical software development management.
- Minimum 2 years proven experience in life-cycle management for medical algorithm development, code review and quality check, including software testing methods such as unit test, system test, regression test, functional test, coverage test, etc. Good to have experience in clinic benchmark test and statistical analysis as well.
- Familiar with basic signal processing, machine learning, statistics or related knowledges for algorithm design.
- Familiar with general regulation / guideline for medical algorithm design, such as ISO 13485, ISO 14971, FDA 21 CFR Part 820, IEC 62304 etc;
- Understanding digital biomarkers or bio-signals regulation / guideline is a plus, such as ECG/PPG (AAMI ANSI EC), blood pressure (IEEE Std 1708), etc.
- Familiar with (FDA generally required) waterfall development mode; Understanding (FDA agile) AAMI TIR45/2012 is a plus.
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Name: Yong Whei Jie
Registration Number: R1110096
EA Licence Number: 02C3423
Octavius, Whei Jie Yong EA License No.: 02C3423 Personnel Registration No.: R1110096