Software Design Assurance Eng
Core
Ensuring regulatory compliance and quality of medical device software through design reviews, risk management, and lifecycle documentation.
Role type
Senior Software Design Assurance Engineer (Medical Devices)
Builds
FDA-regulated medical device software systems
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
Risk Management (ISO 14971), Software Design Controls (IEC 62304), Root Cause Analysis, Software V&V, Traceability, Regulatory Planning, C/C++/C# code interpretation
Preferred skills
ISTQB certification, Agile/SAFe methodologies, Design for Quality (DfQ)
Technologies
C, C++, C#, Object-Oriented Languages
Responsibilities
Lead assessment of software designs by reviewing test and performance data; Track and risk assess software anomalies for pre- and post-market medical device software; Conduct detailed root cause analyses for software quality issues; Assess products and systems to identify defects and design flaws by authoring and executing software test protocols; Ensure compliance across the product software lifecycle by overseeing regulatory planning and execution; Drive regulatory excellence by developing plans and optimizing regulatory processes.
Seniority
Senior, hands-on IC