Who We Need

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

• Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What You Will Do

Job Responsibilities:

• Work independently with members of the business to define and document the scope of new development requirements.

• 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 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.

• Demonstrated ability to meet deadlines, handle and prioritize simultaneous requests, and manage laterally and upwards

• Creative and analytical thinker with strong problem-solving skills

• Must demonstrate exceptional verbal and written communication skills

• Must demonstrate ability to communicate effectively at all levels of the organization

What You Need

Minimum Qualifications

• Minimum six or more years of experience as a Tools administrator or relevant experience is required.

• Bachelor’s degree in Computer Science, Computer Engineering or a related field is preferred.

• Knowledge of Jama Or Jira Or IBM Doors OR Integrity or MKS Integrity workflows, and permission schemes is preferred

Preferred Qualifications:

• Proven ability to design and implement new processes and facilitate user adoption.

• Understanding of engineering lifecycle phases and design control processes is preferred.

• Experience validating third-party tools to comply with the Quality Management system and to follow FDA guidance is preferred.

• Knowledge of System Modeling, Requirement Management, and Test Management best practices when working with multiple concurrent programs is preferred.

• Experience with software and hardware defect tracking processes is preferred.

• The ability to communicate and work with external software vendors is preferred.

• Ability to work independently and manage priorities on multiple tasks is required.

• Excellent verbal and written communication skills is required.

• The ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 is preferred.