Polarion Technical Architect
4 weeks ago
We are seeking a highly skilled and experienced Polarion Technical Architect with specialized expertise in the Medical Devices domain
The ideal candidate will be responsible for designing, implementing, and managing Application Lifecycle Management (ALM) solutions using Polarion ALM
This role requires a deep understanding of regulatory requirements, industry standards, and validation processes specific to the Medical Devices sector, alongside a proven track record of architecting complex ALM systems
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Lead the design and implementation of Polarion ALM solutions tailored to the Medical Devices industry.
Collaborate with cross-functional teams, including R&D, Quality, Regulatory Affairs, and IT, to ensure end-to-end traceability, from requirements through to testing and validation.
Provide expert guidance on regulatory compliance (FDA, ISO 13485, IEC 62304, etc.) and align solutions to meet stringent medical device development standards.
Develop validation strategies, including the management of requirements, test cases, and change control within Polarion.
Design and implement workflows, custom reports, and dashboards to ensure efficient lifecycle management and reporting.
Perform Code Reviews for Polarion Customizations
Offer technical leadership and mentor junior architects, developers, and consultants working on Polarion solutions.
Conduct gap analysis and ensure compliance with regulatory validation for software and hardware components.
Work closely with clients to gather requirements, design technical solutions, and ensure successful deployment and adoption of Polarion solutions.
Serve as a technical liaison between business stakeholders and development teams, ensuring alignment of business needs with technical capabilities.
Manage integration of Polarion ALM with other enterprise systems, such as PLM, ERP, or MES systems.
Maintain deep knowledge of INCOSE guidelines, risk management processes, and industry best practices for requirements quality and traceability.
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Technical Architect
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