Senior Design Quality Engineer - Cardiac Rhythm Management & Diagnostics (CRMDx)
Core
Senior Design Quality Engineer supporting active implantable medical devices, ensuring product safety, quality, and regulatory compliance throughout the lifecycle.
Role type
Senior IC Design Quality Engineer
Builds
Active implantable medical devices (Cardiac Rhythm Management & Diagnostics)
Domain
Medical Devices / Cardiac Rhythm Management
Required skills
Risk Management, Design Controls, Design History File (DHF) management, Hazard Analysis, Fault Tree Analysis, FMEA, Problem-solving methodologies, Validation techniques, Statistical techniques, Usability testing, Design Change management
Preferred skills
Cross-functional collaboration, Regulatory requirements knowledge, Quality strategy development
Technologies
Design History File, Product Specifications, Component Specifications, Prints, Risk Management Tools
Responsibilities
Own and drive deliverables related to Risk Management, Design Controls, Product Performance, Quality, and Compliance; Develop, update, and maintain Design History File and Design Input / Output documentation; Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs); Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues; Work within a cross-functional team to identify and implement effective controls for new technology in complex medical devices; Write various technical documentation for procedure execution, technical rationale, and evidence of the development process; Develops and implements quality strategies; Support Post Market activities of risk based on post-market signals; Actively participate in the Design Change process; Demonstrate good working knowledge and application of validation and statistical techniques; Support the verification, validation, and usability testing; Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.