Senior Development Quality Engineer
Core
Lead risk management strategy and quality assurance for Class III implantable medical devices throughout the product lifecycle, ensuring compliance with global regulatory standards.
Role type
Senior Design Quality Engineer (Medical Devices)
Builds
Class III medical devices for chronic pain and movement disorders
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
risk management strategy, root cause investigation, statistical data analysis, regulatory compliance documentation, hazard identification, benefit-risk tradeoff analysis, cross-functional collaboration, design history file management, corrective action prioritization
Preferred skills
medical device design and development experience, advanced quality engineering methodologies
Technologies
ISO 14971, FDA QMSR, EU MDR, ISO 13485, 21 CFR Part 820, EN 45502-1, ISO 14708
Responsibilities
Lead and influence the integration of risk management into product development and post-market activities; Partner with Clinical, Medical Safety, and Regulatory teams to generate risk-based evidence; Drive development of verifiable customer and system requirements; Ensure complete and inspection-ready Design History File documentation; Lead cross-functional risk reviews regarding risk acceptability and control effectiveness; Apply problem-solving methodologies to investigate complex quality issues.
Seniority
Senior, hands-on IC
