THIS JOB IS NO LONGER AVAILABLE. THIS IS ARCHIVAL INFORMATION. Systems Engineer, New York, New York
Systems Engineer, New York, New York
• 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.
About the role: Work with technical staff to understand problems with software and develops specifications to resolve them. Resolve customer complaints and respond to suggestions for improvements and enhancements from third-party customers. Location: Rochester, NY
You will: Manage requirements across the whole lifecycle. This will include capturing and analyzing all partner requirements – maintaining full traceability at all levels (from requirement definition, planning/scheduling, to development, testing, defect management, to cycle and release management), and documenting the results of verification activities to demonstrate compliance. Migrate requirements from DOORS to QC, Develop coverage. Build any required reporting templates for requirements and trace matrices - export to Windchill for system of record. Simplify Workflow - There is an implementation that needs to be simplified (Quality Center scripting changes for ease of use)Integration of risk management plan (RMP) sheet into QC and allow for updating on new import and updated RMP Sheet Integration with Testing tools, Application automation, Issue / incident management tools, Agile team tools for User stories / Epics / Releases Be a project resource to create system documentation including : User needs, Design Input, Risk management and planning in cooperation with test team.
You'll need: Expertise working with Quality center Enterprise. You have about 10+ years of experience in developing medical devices and have knowledge of Design Control, ISO13485 and related regulatory requirements. Create requirements documents, including exporting DOORS™ templatesExperience with IVD Medical Device Development Process in compliance with applicable FDA and state regulations, and standards including ISO 13485.
Skills & Experience
DOORS, DXL for DOORS, Requirements Analysis, • Working experience in both Assay and Medical devices • Would have working experience in IVD industries
Cyient 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.
New York, NY
1401 NOLAN RYAN EXPY
ARLINGTON, TX 76011