System Engineer

  • Pune
  • Capgemini
<div ccp_infra_copy_id="62a8f9c7-7260-4df4-b056-1368862eefef" ccp_infra_timestamp="1714464090374" ccp_infra_user_hash="405218107" ccp_infra_version="3" data-ccp-timestamp="1714464090374">  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