Polarion ALM Business Systems Administrator- R&D || Remote role

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