Work independently with members of the business to define and document the scope of new development requirements in an Agile environment.
A demonstrated ability to understand and articulate complex requirements
Ability to critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a general understanding and distinguish user requests from the underlying true needs
Ability to assess the impact of new requirements on all upstream and downstream applications, systems and processes
Work with our management team to establish suitable processes to support administrative development, and change management activities.
Document standards, guidelines, templates, and best practice procedures for both
administrators and users of the system. * Administrative owner of the tools such as Jama software requirements management tool
Perform and own tasks including, but not limited to:
User account maintenance
Create filters and custom reports or dashboards for each project, as needed.
Customize workflows for multiple projects and maintain configuration of the tools.
Manage release cycles and validate the software tools.
Upgrade, backup, and baseline the project folders within each software tool.
Work closely with Quality engineering team for compliance.
What Will You Need: Basic Qualifications:
Bachelor's degree in Computer Science, Computer Engineering or related field.
Minimum 4 years of experience as a Tools administrator or relevant experience.
Basic know how of scripting and programming in any language.
Knowledge of Jama or any other ALM tool workflows and permission schemes.
Preferred Qualifications:
Proven ability to design and implement new processes and facilitate user adoption.
Understanding of engineering lifecycle phases and design control processes.
Experience in validating third party tools to comply with Quality Management system and to follow FDA guidance.
Knowledge of System Modeling, Requirement Management and Test Management best practices when working with multiple concurrent programs.
Experience with software and hardware defect tracking processes.
Previous experience working in a SCRUM or Agile environment preferred
Ability to work independently and manage priorities on multiple tasks is required.
Excellent verbal and written communication skills and ability to work with external software vendors
Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.