System Engineer

Experience level – Experienced

Contract type – Permanent

Location – Pune

Business unit – Engineering And R And D Services

Academic Background: bachelor’s degree in engineering life science or other relevant areas
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
·       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
Mahesh Wabale
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