DOORS Systems Analyst

Spectraforce Technologies

Nov 20, 2024
Title: DOORS Systems Analyst Location: 100% remote Duration: 12 Months Position is Remote but will mainly be working on Pacific Time Zone. Job Description: Responsible for configuration of IBM Rationale SaaS systems, specifically DOORS Next Gen (DNG) and Engineering Test Management (ETM). Must have significant experience leading implementation and configuration of those systems. Including project management, working cooperatively with subject matter experts, knowledge and implementation of best practices of medical device product development utilizing the specific IBM systems. Nice to have additional expertise in medical devices computer systems validation and 21 CFR Part 11 requirements. No education requirements other than having at least a high school diploma. Minimum of 5 years' experience but strongly prefer over 10 years. MUST have DOORS Next Gen (DNG) and Engineering Test Management (ETM) experience with implementation and configuration. Must be Doors Next Gen exp as will not review DOORS Classic exp. Will be implementing and configuring the system with stakeholders Must have Project Management exp. Ability to work with multiple SME (subject matter experts) Med device exp. preferred but not required. Top 3 skills: 1. Min 5 years exp. configuring DOORS Next Gen and ETM 2. Some Admin exp. 3. Project Management exp. Remote from any time zone but will mainly be working with people in the Pacific Time zone so if East Coast, may have to work later