Systems Design Quality Engineer
Core
Ensures design control process compliance and validates product designs (hardware/software) for safety, reliability, and manufacturability throughout the product lifecycle.
Role type
Senior IC quality engineering specialist (medical device R&D)
Builds
Validated medical device designs and compliant quality systems
Domain
Medical device industry + Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control process management, Statistical process validation, Root cause analysis, Risk assessment, Regulatory compliance (IEC 62304/82304), CAPA methodologies, Design verification/validation planning, Technical documentation, Data analysis, Continuous improvement
Preferred skills
Medical device R&D experience, Six Sigma Green Belt, Hardware/software integration experience
Technologies
IEC 62304, IEC 82304, Statistical tools, Post-market surveillance analytics
Responsibilities
Guide implementation of process validation plans using statistical tools, Ensure smooth execution of design control from inputs to transfer, Review quality engineering documents for hardware/software/system designs, Propose and initiate quality improvement projects integrating reliability and PMS plans, Evaluate product designs and perform root cause analysis for quality deficiencies, Validate essential design inputs (usability, reliability, safety), Support quality audits and inspections, Apply continuous improvement techniques to enhance quality practices
Seniority
Mid-Senior, hands-on IC