What are the responsibilities and job description for the Design Quality Engineer position at Katalyst HealthCares and Life Sciences?
Responsibilities :
- Ensure design verification and validation activities meet regulatory requirements.
- Support new product development and sustaining engineering projects, ensuring compliance with FDA QSR, ISO 13485, and ISO 14971.
- Collaborate with R&D, Regulatory, and Quality teams to manage design risk and test method validation.
- Lead Health Risk Assessments for market products and evaluate design change impacts.
- Assess and document design inputs, usability, reliability, and biocompatibility standards.
Requirements :
