Design Assurance Engineer II
Core
Ensuring safety, efficacy, and compliance of electrophysiology medical devices through design verification, validation, and regulatory adherence.
Role type
Design Assurance Engineer II (Medical Devices)
Builds
Ablation and diagnostic catheters for treating atrial fibrillation
Domain
Healthcare / 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, Applied statistics, Design of experiments, Regulatory compliance (FDA, GMP, ISO 13485, IEC 60601, ISO 14971), Technical analysis of requirements
Preferred skills
Biomedical or Mechanical Engineering background, Electrophysiology or cardiovascular device experience, ASQ certification (CQE, CQA)
Technologies
Minitab
Responsibilities
Lead and implement complex development projects including quality improvement initiatives, Execute holistic design verification/validation strategies, Lead design characterization activities, Support design test and inspection method development, Ensure DHF content integrity and regulatory compliance, Support internal and external audit responses
Seniority
Mid-level, hands-on IC