Job Description
Key Responsibilities
Data Migration: Generate reports, assist in data migration tool development, perform testing, and perform tasks necessary for successful data migration.
System Administration: Administer and maintain Polarion ALM systems, ensuring optimal performance and availability for all users while ensuring governance with corporate QMS, Security, and AI procedures Coordinate user access reviews.
Configuration Management: Configure projects, manage repositories, and customize workflows to meet the specifications of various teams and projects. Support AI-enabled capabilities where approved.
User Management: Manage user accounts, roles, permissions, licenses, and SSO set-up for Polarion systems.
Training and Support: Provide training and support to team members on ALM functionalities and best practices.
Documentation: Develop and maintain documentation related to ALM processes, workflows, and user guides.
Integration: Integrate Polarion with other tools and systems used within the organization, including REST API/Mulesoft integrations
Monitoring and Reporting: Monitor system performance, build and generate SQL/Velocity reports, and provide insights to improve ALM processes and performance optimizations
Troubleshooting: Identify and resolve issues related to ALM systems promptly.
Education and Experience/Minimum Requirements
B.
S. in Engineering or technical discipline
2+ years of experience working with R&D ALM systems and experience managing workflow designs
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 an ALM or PLM tool
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:
Four (4) years of higher education
Three (3) 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 systems
Ability to construct custom dashboards and reporting metrics from ALM tools
Specific experience with Polarion ALM to implement design controls
Travel Requirements
This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired)
Domestic travel as necessary domestically to support in-person training/demonstrations