This role focuses on planning and governance activities related to Application Lifecycle Management (ALM) tools, covering software development processes (such as those included in SLDC and/or ADLM), as well as their monitoring and maintenance processes as manufacturers.
Key processes to be covered are software requirements definition and management, software change and configuration management, software project planning, with a current focus on agile planning, work item management, quality management, including defect management. Other key elements include: reporting, workflow, integration to version management, support for wikis and collaboration, strong facilities for integration to other ALM tools.
Validation of these tools by focusing on our intended use, along with the appropriate generation of records are also an important part of this function.
Key Accountabilities Responsible for ensuring that the requirements and test management tool meets the needs of the business and complies with regulatory requirements.
Coordinate with other departments to meet other ALM needs.
Installation, configuration, and administration of the tool setup in cooperation with IT department and suppliers.
Validation of the tool. Ensure and demonstrate (with records) that the tool complies with the standards required for the development of medical devices.
Maintaining knowledge and understanding of the latest requirements management methodologies and best practices.
Harmonize methods, records and workflows among all the projects.
Networking/Key Relationships This position requires cooperating with all project teams to know at all times the actual status of ALM needs and initiatives and work with them to introduce ALM changes and improvements.
This position also requires tied cooperation with IT department to coordinate IT hosting and networking required in the deployment of ALM solutions.
In addition, it also works with external ALM service providers to increase the specialization and quality of the services provided.
Minimum Knowledge & Experience Required for the Position: Education : Engineer BS or MS, Computer science BS or MS, or other technical degree.
Experience : A minimum of 3 years as an ALM Engineer.
Skills & Capabilities: Experience with application management.
Experience in requirement tool setup, development, and maintenance. It is a strong advantage your experience in JIRA and Confluence.
Proven experiences in working requirements and test cases for medical devices. It is a strong advantage your experience in JAMA.
Excellent understanding of Agile methodologies.
Excellent communication and collaboration skills.
Knowledge and understanding of Software Engineering Process.
Knowledge and understanding of regulated environments (such as the health-care market) and related requirements.
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