Senior Engineer - Tools Support

Qualification:

Experience:

• 4 8 years of Hands-on experience with Application Lifecycle Management (ALM) tools, model-based systems engineering (MBSE), and a strong understanding of compliance, quality management, and IT service processes.
• Relevant certifications in ALM tools, ITIL, or quality management systems will add value.

Responsibility:

• Support for Enterprise Architect system modelling tool including helper tools and Add-Ins, covering 1st and 2nd level support.
• Apply and articulate Model Based Systems Engineering (MBSE) concepts and viewpoints across project phases
• Utilize software development tools, with a focus on code review applications, to enhance collaborative development and code quality (Adopt DevOps)
• Maintain awareness and support organizational compliance with GDPR requirements and ISO 27001 information security standards
• Support the implementation of ISO 13485:2016 and 21CFR requirements for quality management systems, particularly relevant to medical device software
• Support end-users by addressing their technical issues, troubleshooting, and providing timely resolutions related to ALM tools and associated platforms.
• Contribute to continuous process improvement.

Skills

Mandatory

• Knowledge of ALM tools, and requirements management tools like Polarion, IBM Doors Next Gen (DNG), as well as modelling tools such as Magic Draw, IBM Rhapsody, and Enterprise Architect.
• Exhibit strong proficiency in Azure DevOps, including Kanban board utilization, effective demand management, and product backlog prioritization.
• Understanding of ISO 27001 information security standards, ISO 13485:2016 and 21CFR requirements for quality management systems, particularly relevant to medical device software.

Optional

• Understanding of Cybersecurity concepts as per ISO Standards are highly recommended & Ability to handle vulnerable items related to Application layer is preferred.
• Passion for exploring new tools and technologies with quick learning skills.
• Ability to understand user needs and support them with efficient collaboration and communication skills.
• Awareness on Medical Imaging domain and/or Clinical Workflow knowledge will be an added advantage