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System Engineer

3 months ago

Pune, Maharashtra, India Capgemini Full time
System Engineer 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