Senior Design Assurance Engineer
Core
Ensures risk management and design controls for Philips' Image Guided Therapy Devices during sustaining and new product development.
Role type
Senior Design Assurance Engineer (Medical Devices)
Builds
Image Guided Therapy Devices (IGTD)
Domain
Medical Devices / Health Technology
Deliverable
client delivery
Required skills
Risk Management (ISO 14971), Design Controls, Quality Management Systems (ISO 13485, 21CFR), Statistical Analysis, Component Qualification, Design Verification Planning, Process Validation Planning, Medical Device Documentation Review, Auditing Design History Files
Preferred skills
ASQ certifications
Technologies
ISO 14971, ISO 13485, 21CFR Part 820, EU MDR
Responsibilities
Update risk documents and component qualification based on validation and field feedback; Review design requirement rationales and test method validation; Determine sampling plans and measurement techniques; Plan and conduct design verification and process validation activities; Analyze quality data for trending and KPIs.
Seniority
Senior, hands-on IC