Ensure the biological safety and performance of Philips Hospital Patient Monitoring products by leading product reprocessing validation and material compatibility testing
Job Summary
Ensure the biological safety and performance of Philips Hospital Patient Monitoring products by leading product reprocessing validation and material compatibility testing.
Support the creation and maintenance of safe and effective reprocessing Instructions for Use (IFU) in collaboration with cross-functional teams.
Ensure that testing meets all international and domestic regulatory requirements, including ISO, FDA, EU MDR, GLP, Japan, and APAC regulations.
Matching Summary
Ensure the biological safety and performance of Philips Hospital Patient Monitoring products by leading product reprocessing validation and material compatibility testing.
Skills & Requirements
Must-have
Develop and validate reprocessing methods
ISO 17664 Series compliance
Material compatibility testing
Risk assessments and evaluations
Regulatory submissions support
Global medical device regulations
Nice-to-have
Project management skills
Effective communication skills
Proficient in statistics
Microsoft suite proficiency
Product development process understanding
Key Requirements
Bachelor's degree in relevant engineering or science field
Minimum 2 years of reprocessing verification & validation experience
Working understanding of global medical device regulations
Experience with Contract Resource Organizations (CROs)