Job 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 |
Company
Capgemini
Job Posted
7 months ago
Job Type
Full-time
WorkMode
On-site
Experience Level
3-7 Years
Category
Locations
Pune, Maharashtra, India
Qualification
Applicants
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