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DHF Remediation Engineer

4.00 to 6.00 Years   Hyderabad   15 Feb, 2022
Cyient Limited
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    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 defence, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy.Job DescriptionMedical devices product engineering, product design, Gap assessment, Remediation, Risk Management, MRI(magnetic resonance), Verification and Validation of Medical devices.Need to have Technical leadership role on sustenance/DHF Remediation projectsFamiliar with FDA Quality System Regulations 21 CFR Part 820.30, ISO 13485, Six Sigma conceptsHands on experience in CAD/CAM tools like Creo, Solidworks and AutocadHands on experience on PLM tools like Windchill, SAP 6.0 and statistical tools like Minitab.Design Tools : Creo 2.0, Solidworks 2015 and Autocad 2015.PLM Tools : WIndchill, SAP 6.0Management Tools : PMsmart, Microsoft Project PlanVerification Tools : MinitabDomain : Medical,Need to have experience in Developing and maintaining Design History Files (DHF) for various projects. DHF includes product design specification, engineering drawings, product and process validations, packaging and shelf life verifications.Coordinating skills of a project team made up of members of Quality Assurance, Medical, Regulatory, Marketing and Manufacturing groups.Need to have knowledge on Developing Verification/ Validation Plans, Protocols, Test Case documents for system/subsystem testing.Familiar with FDA Quality System Regulations 21 CFR Part 820.30, ISO 13485,EU-MDR Six Sigma concepts.Skills & ExperienceDHF Remediation, Global Regulatory, tClinical/ medical writing /regulatory writing experience tFDA (510K) submissions tExcellent communication skills both written and verbalCyient is an Equal Opportunity Employer.Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter.,

Keyskills :
continuous improvement facilitationdesign historyquality systemmicrosoft projectmedical writingproduct designiso 13485six sigmarisk managementshelf lifequality assuranceplm tools

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