Design Quality Engineer III - Interventional Cardiology
Core
Ensure safety, quality, and compliance of medical electrical equipment/systems (MEE) within Interventional Cardiology by applying design controls.
Role type
Sustaining Design Quality Engineer III
Builds
Medical electrical equipment/systems for Interventional Cardiology
Domain
Medical Devices / Regulatory Compliance
Required skills
Design controls, Risk management, Design Verification, Design Validation, CAPA, Quality System Requirements, Good Documentation Practices, Problem-solving methodologies
Preferred skills
Mechanical/Electrical/Biomedical engineering background, Medical device standards compliance, Corrective and preventive action experience
Responsibilities
Own design change projects including scoping, assessment, and implementation; Develop, update, and maintain Design History File and Design Input/Output documentation; Update and maintain risk management files (Hazard Analysis, Task Analysis, Design FMEA); Develop and execute Design Verification, Design Validation, and Usability protocols and reports; Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs; Apply systematic problem-solving methodologies to resolve quality issues.
Seniority
Mid-level, hands-on IC