Design Assurance Engineer II
Core
Ensuring design and process compliance for disposable ablation catheters through verification, validation, and regulatory support.
Role type
Design Assurance Engineer
Builds
Disposable ablation catheters for treating atrial fibrillation
Domain
Medical devices / Electrophysiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design verification and validation techniques, statistical analysis and design of experiments, root cause investigation, regulatory compliance (FDA/ISO), CAPA management, NCMR ownership
Preferred skills
Medical device experience, knowledge of IEC 60601 and ISO 14971
Technologies
Minitab
Responsibilities
Execute holistic design verification and validation strategies, lead root cause investigations and corrective actions, ensure DHF/DMR/DHR content integrity, support design and process test method development, participate in regulatory inspections
Seniority
Mid-level, hands-on IC