From: <npune@deegit.com>
Date: Fri, Feb 12, 2016 at 8:55 PM
Subject: Medical Devices Testing // Carlsbad: California // 6+Months
To:
Hi,
Please go through the below our direct client requirement and kindly let me if you are interested.
Job Role: Medical Devices Testing
Location: Carlsbad: California
Duration: 6+Months
Job description:
· 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 development lifecycle
· 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 skills
· Ability to effectively work on project teams.
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