System Engineer
1 month ago
Academic Background: bachelors 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
& ISO :
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
and/or experience in conducting risk management activities, e.g. hazard analyses, FTA, and FMEA.
Knowledge on MDD 93/42/EEC and MDR /
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 -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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