Description

You will manage the IBM Rational DOORS requirements database and lead system implementation and configuration efforts.

Responsibilities

• Manage the IBM Rational DOORS requirements database, including importing source files, creating attributes, and managing user access.
• Create and maintain link modules and link sets for traceability, verification, and analysis.
• Control changes by locking documents, proposing modifications, reviewing effectivity, and exporting change notices.
• Provide technical guidance, training, and reporting to program users to ensure efficient tool usage.
• Execute product definition, system architecture, requirements management, risk analysis, and hazard analysis.

Required Skills

• Mandatory experience with DOORS Next Gen (DNG) administration and management.
• Proven experience with Engineering Test Management (ETM) configuration.
• 7+ years of professional experience in systems analysis or administration.
• Expertise in IBM tool integration and configuration.
• Strong project management experience, including leading implementations and working with Subject Matter Experts.
• Proficiency in Windows and Linux environments.
• Ability to perform risk analysis and hazard analysis.
• Bachelor's degree in Computer Science, IT, Systems Engineering, or a related field.

Preferred Skills

• Experience with Medical Device computer systems validation and 21 CFR Part 11 requirements.
• Proficiency in DXL scripting and custom reporting.

Key Skills

Education

Bachelor's degree