Job Title: Polarion Senior Solution Architect
Location: Massachusetts, MA (Onsite)
Duration/Term: Long Term Contract

Key Responsibilities:

• Design: Lead the design and implementation of Polarion ALM solutions tailored to the Medical Devices industry.
• Collaboration: Collaborate with cross-functional teams, including R&D, Quality, Regulatory Affairs, and IT, to ensure traceability from requirements to testing and validation.
• Compliance: Provide expert guidance on regulatory compliance (FDA, ISO 13485, IEC 62304) and align solutions with medical device standards.
• Validation Strategies: Develop validation strategies, managing requirements, test cases, and change control within Polarion.
• Workflows and Reporting: Design and implement workflows, custom reports, and dashboards to ensure efficient lifecycle management and reporting.
• Code Reviews: Perform code reviews for Polarion customizations.
• Leadership: Offer technical leadership and mentor junior architects, developers, and consultants working on Polarion solutions.
• Gap Analysis: Conduct gap analysis and ensure compliance with regulatory validation for software and hardware components.
• Client Engagement: Work closely with clients to gather requirements, design technical solutions, and ensure successful deployment of Polarion solutions.
• Liaison: Serve as a technical liaison between business stakeholders and development teams, aligning business needs with technical capabilities.
• Integration: Manage the integration of Polarion ALM with other enterprise systems, such as PLM, ERP, or MES systems.

Key Qualifications

• 7+ years of experience working with Polarion ALM in regulated environments.
• 4+ years of experience in the Medical Devices domain.
• Bachelor's or Master s degree in Computer Science, Engineering, or a related field.
• Strong understanding of medical device regulations (FDA 21 CFR Part 820, ISO 13485, IEC 62304).
• Proven expertise in designing ALM solutions with a focus on requirements management, risk management, and validation workflows.
• Experience with software development methodologies (Agile, Waterfall).
• Familiarity with integrating ALM systems with other enterprise tools like PLM, ERP, and MES.

Key Skills: Polarion ALM, Medical Device Compliance, ALM Solutions Design, Regulatory Compliance (FDA, ISO 13485, IEC 62304), Agile and Waterfall Methodologies, System Integration, Client Engagement, Workflow Design, Requirements Management.