Polarion Senior Solution Architect
Polarion Senior Solution Architect
Posted on :
27-10-2024
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Job Description
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 crossfunctional 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.
- Bachelors 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.
Employment Type
Full Time
Key Skills
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