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Wallet icon Coin icon Rate 120 000 CZK - 170 000 CZK / month info
Timer icon Form of cooperation Full-time / 40% Remote
Briefcase icon Sector Healthcare
Location icon Location Praha

info The reward is calculated upon delivery of 20 MD per month (1MD=8h)

Project duration 12 months with the possibility of extension
Period of cooperation 02.12.2024 - 02.12.2025
Start date 02.12.2024 or by agreement
Technology
  • Java
Languages
  • English flag English - active, B2/C1/C2

Project description

  • leading the design and implementation of Polarion ALM solutions specifically for the medical device industry
  • working with cross-functional teams, including R&D, QA, Regulatory Affairs, and IT, to ensure end-to-end traceability from requirements to testing and validation
  • providing expert advice on compliance with regulatory standards (FDA, ISO 13485, IEC 62304, etc.) and customizing solutions to meet stringent medical device development standards
  • creating validation strategies and managing requirements, test cases and change management within Polarion ALM
  • design and implementation of workflows, custom reports and dashboards for effective lifecycle management and reporting
  • performing code review for Polarion customizations
  • providing technical guidance and mentoring to junior architects, developers and consultants working on Polarion solutions
  • performing gap analysis and ensuring compliance with software and hardware validation requirements
  • working closely with customers to gather requirements, design technical solutions and ensure successful deployment and adoption of Polarion solutions
  • acting as a technical link between business partners and development teams, ensuring alignment of business needs with technical capabilities

Project requirements

  • advanced knowledge of Polarion ALM and experience implementing ALM solutions in the field of medical devices
  • knowledge of regulatory standards and regulations for medical devices, especially FDA, ISO 13485, IEC 62304
  • experience with the design and management of complex ALM systems
  • strong analytical skills and experience developing and validating workflows, reports and dashboards in Polarion
  • experience in project management and mentoring of junior team members
  • English language at a communicative level
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