Polarion Medical Devices ALM Solutions Architect
1 week 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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Main Responsibilities:
- 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.
Key Skills:
- Detailed knowledge of Polarion ALM and its applications in the Medical Devices industry.
- Strong understanding of regulatory requirements and industry standards for Medical Devices.
- Excellent collaboration and communication skills for working with cross-functional teams.
- Proven experience in designing and implementing complex ALM systems.
- Strong technical leadership and mentoring skills.
- Ability to work effectively with clients and stakeholders to gather requirements and design solutions.
Benefits:
- $120,000 - $160,000 per year salary, depending on experience.
- A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
- Opportunities for career growth and professional development.
- A dynamic and supportive work environment.
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