
Senior Engineer
3 days ago
Qualification: B.E/MCA degree (CSE/ISE/Electronics)
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
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