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System Engineer

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

Ref: 1807476

Posted on: Apr 30, 2024

Experience level: Experienced

Contract Type: Permanent

Location:

Pune, MH, IN

Department: Manufacturing, Automotive & Life Sciences

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