Hope You Are Doing Well...
This is Ravi Krishna from Deegit Inc. We do have an urgent Position
Engineer with Medical Devices exp at CA*. Please find the requirement below
for your review
*Role : Validation Engineer with Medical Devices exp*
*Location : Carlsbad, CA*
*Duration: 6+ Months*
· Working knowledge of the FDA Quality System Regulation, ISO
13485, and the Medical Device Directive
· Skilled in product risk assessment (ISO 14971), requirements
management and tracing, defect tracking, configuration management
techniques, and knowledge of how these are applied in the software
· Experience in Agile software development techniques and IEC 62304
requirements, versed in guidance documents such as TIR-45, IEC TR 80002-1
and Cyber security guidance from FDA
· Understanding of current Software Quality techniques, software
industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System
Regulations and their impact on internal procedures, software quality,
safety and efficacy of products
· Experience in risk evaluation techniques, such as Product Risk
Assessment and FMEA including software risk assessment and software FMEA
· Familiar with reliability analysis and test methods, including
software reliability modeling
· Working knowledge of C and C++
· Good verbal (including presentation) and written communication
· Ability to effectively work on project teams.
*Ravi Krishna | Sr Technical Recruiter*
*DeegitTM Inc* | Technology Consulting
1900 E Golf Rd., Suite 925 | Schaumburg, IL 60173
*Phone* (847) 440 2436 Ext. 332
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