Polarion Solution Architect, Polarion ALM - Mega Cloud Lab

Polarion Senior Solution Architect

We are seeking a highly skilled and experienced Polarion Senior Solution 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.

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.

Qualifications

·& & & & & & & & Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field.

·& & & & & & & & Strong understanding of medical device regulations such as FDA 21 CFR Part 820, ISO 13485, and IEC 62304.

·& & & & & & & & Proven experience designing end-to-end ALM solutions, including requirements management, risk management, testing, and validation workflows.

·& & & & & & & & Familiarity with software development methodologies (Agile, Waterfall) and system engineering best practices.

·& & & & & & & & Strong experience with integration frameworks (e.g., APIs, web services) to connect Polarion ALM to third-party tools.

·& & & & & & & & Excellent communication and interpersonal skills, with the ability to interact with business stakeholders, technical teams, and executive leadership.

·& & & & & & & & Experience with requirements quality analysis using INCOSE guidelines.

·& & & & & & & & Experience in mentoring or leading development teams in ALM best practices.

·& & & & & & & & Strong problem-solving skills and the ability to work in a fast-paced, regulated environment.

·& & & & & & & & Minimum of 7+ years of experience working with Polarion ALM in complex, regulated environments, with at least 4+ years in the Medical Devices domain.