| Project Manager with ALM :: USC or GC only ::Remote :: Life science industry exp preferred at Industry, Texas, USA |
| Email: [email protected] |
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From: SONALI GUPTA, KPG99 [email protected] Reply to: [email protected] Hey! Please Read the below Requirement and share your resume and also please let me know your visa status if interested. Project Manager with ALM 100% Remote Visa : USC/GC Only Duration: 6+ Months Life science industry exp preferred but not required. Responsibilities Administer and maintain ALM systems (i.e. Helix/Siemens Polarion) necessary for best in class implementation of design elements including but not limited to: design requirements, risk management artifacts, verification testing/reporting, tracing and product issue tracking. Lead/coordinate data migration between ALM tools working with SMEs ensuring minimal impacts to existing data configurations. Ensure proper configuration for efficient and clear traceability among design input, design output, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file. Provide access and training to new ALM users and Managers on usage of ALM modules. Responsible for standardizing, implementing, and maintaining, template's within ALM tools. Drive integration of external tools with ALM ensuring proper synchronization and mapping. Create and release procedures defining general navigation/use and specific customizations/integrations required when optimizing tool capabilities Develop metrics, dashboards and reports across different functions providing meaningful operational/performance metrics and status. Collaborate with IT as needed ensuring statements of work, purchase orders, and invoices are current with ALM vendors/partners. Represent R&D as the liaison for existing PLM tools (i.e. Arena) as required Perform other general administration duties as required. Education and Experience/Minimum Requirements B.S. in Engineering or technical discipline 8+ years of experience working with R&D ALM systems, implementing, and customizing complex workflows, data migration, account permissions and training modules. Excellent management skills: experience and capability managing collaboration under a Quality Management System (QMS), as part of a cross-functional team that includes development/verification/validation/procurement/manufacturing/regulatory and quality experts. Demonstrated expertise in product development and commercialization activities related to Design Controls utilizing ALM or PLM tools. Demonstrated examples of collaboration skills, effectively working in a team environment Experience managing inputs from several sources, self-organized, cross-functional project teams in a matrixed environment. Preferred Skills and Competencies: Two (2) years of higher education Five (5) years of experience working in a regulated medical device (Class 1, 2 or 3) industry using design and development processes in compliance with FDA 21 CFR part 820, ISO 13485, IEC 62304, or ISO 14971. Experience with integration of external tools into ALM system Demonstrated experience with Confluence administration and customizing spaces Ability to construct custom dashboards and reporting metrics from ALM tools Team player with ability to mentor team members Travel Requirements This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; Keywords: rlang information technology green card |
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| 01:21 AM 21-Sep-23 |