Technical Writer - Biomedical Engineering null

Cyient is a global engineering and technology solutions company. As a Design, Build and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ahead of the curve. We leverage digital technologies, advanced analytics capabilities, and our domain knowledge and technical expertise, to solve complex business problems.

With over 15,000 employees globally, we partner with clients to operate as part of their extended team in ways that best suit their organization’s culture and requirements. Our industry focus includes aerospace and defense, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy.

• As per FY 22-23, 14 Freshers (campus and off-campus) with Specialization as below.
• Need freshers allotment for projects
• Biomedical Engineering (BME): 14

Job Summary

• Ability to support and execute activities related to product development teams and cross-functional projects.
• Excellent written and verbal communication skills. Proficient in Microsoft Office
• Thorough working knowledge of applicable FDA, ISO, EU, and/or other region-specific medical device regulations, requirements, and standards.
• 510(k) awareness and Regulatory Affairs Certification (RAC) preferred.
• Ability to work under limited supervision with FDA, Notified Body, Authorized Representatives, 3rd party license holders, and other global regulatory agencies.
• Technical writing – reports and technical justification.
• Develop an understanding of functional / system testing of medical devices.
• Carry out Root cause analysis and work on NC/CAPA resolution.

Awareness (Preferred)

• DHF Remediation, Risk management, Change control Management, NC/CAPA, Design verification, ISO 13485, ISO 14971
• EU-MDR implementation
• FDA (510K) submission.
• Risk management and risk analysis activities.
• Protocols and procedures.

Essential Job Duties

• Research and review the inputs and determine their effect on technical manuals and publications.
• Create/Revise technical content in Simplified Technical English based on the engineering inputs.
• Provide written data in defined standards using Client specific tools for technical manuals.
• Provide input and suggestions for the continuous improvement of the various Department procedures, controls, flows, and systems, and become familiar with Cyient internal policies and procedures.
• Maintain involvement in day-to-day Cyeint operations to ensure that the highest level of technical support is maintained at all times.
• Responsible for developing the work execution methodology and development of standard work instructions. Ensure that all quality metrics are within the agreed parameters.

Skills & Experience

• Technical author, Technical Illustrations, Technical Publication Authoring Tool-Arbor text editor, MS Word