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System Engineer
Location:
Pune, Maharashtra
Description:
System Engineer Academic Background: bachelor’s degree in engineering life science or other relevant areas Grade: Skill Requirement • 5- 8 years of total experience out of which 2-4 years of experience in within medical device industry is mandatory • Good understanding of the QSR / QMS requirements as per 21 CFR Part 820 & ISO 13485:2016 • Thorough understanding of requirements management; from user needs through verification and validation; experience with requirements management tools. • Knowledge of requirements traceability and generating trace matrix • Experience in the development of system architectures. • Working knowledge of ISO 14971 and/or experience in conducting risk management activities, e.g. hazard analyses, FTA, and FMEA. • Knowledge on MDD 93/42/EEC and MDR 2017/745 • Familiarity with the Design Controls in Medical Devices • Working Knowledge on the applicable standards • Experience with EU MDD/MDR Remediation and DHF remediation projects Responsibilities: · Gap assesment with respect to medical device directives/regulations and applicable standards. · Documents system architecture and design control elements by writing documents, reports, and memos. · Collaborates in the translation of customer needs into technical requirements, engaging the field, marketing, service and other functions as needed. · Provides expertise and conducts evaluation of validation and verification activities. · Assist with industry-based standards testing for safety and EMC according to 60601-1 · Supports the risk analysis for the project. · Works with a cross-functional team and serves as an R&D representative on cross-functional deliverables. · Working in a global delivery model
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More About this Listing: System Engineer
System Engineer is a Engineering Engineer Job at Capgemini located in Pune MH. Find other listings like System Engineer by searching Oodle for Engineering Engineer Jobs.
System Engineer is a Engineering Engineer Job at Capgemini located in Pune MH. Find other listings like System Engineer by searching Oodle for Engineering Engineer Jobs.