Requirement Tools Engineer

Requirements Tools Engineer (NO C2C - W2 ONLY) Location: Onsite in Pleasanton, CA (OPEN TO RELOCATION AT YOUR OWN EXPENSE) Duration: Contract (initial term, potential extension) Business Unit: Heart Failure (R&D) Pay: $60-65/hr Overview We are seeking a Requirements Tools Engineer to support medical device product development by enabling and maintaining enterprise requirements management infrastructure. This role focuses on administering, configuring, and optimizing requirements management tools, supporting data migration from legacy systems, and ensuring data integrity, traceability, and regulatory compliance. You will partner with cross-functional engineering teams to establish scalable requirements structures, best practices, and governance frameworks that support efficient development and design control processes. Key Responsibilities • Plan and execute migration of requirements and related data from legacy tools (e.g., DOORS, Jama, Excel, Jira) into modern platforms while ensuring data integrity and traceability • Administer, configure, and maintain enterprise requirements management tools (e.g., hierarchies, workflows, templates, versioning, baselining) • Develop and maintain requirements management plans, including structure, governance, and linkage to design control documentation • Create and standardize requirements templates, traceability frameworks, and best practices aligned with quality and regulatory standards • Maintain requirements databases and support integrations, automation, and tool enhancements to improve usability and efficiency • Provide training, documentation, and ongoing support to engineering teams as the subject matter expert for requirements tools and processes • Collaborate with cross-functional stakeholders to scale requirements frameworks across programs Required Qualifications • Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or related field • 5+ years of hands-on experience administering or configuring enterprise requirements management tools (e.g., Codebeamer, DOORS, Jama, or similar) • Experience working in regulated development environments (e.g., medical device, healthcare, or similar) • Hands-on experience with requirements/data migration from legacy systems • Strong understanding of requirements management, traceability, and design control principles • Excellent communication skills with the ability to train and support technical teams • Ability to work effectively in a collaborative, cross-functional environment Preferred Qualifications • Experience as a tool administrator, configuration owner, or advanced power user • Experience building or scaling requirements frameworks across large or multi-team programs • Familiarity with FDA regulations (21 CFR Part 820) and quality systems • Experience supporting software-driven, connected, or mobile medical devices • Experience with integrations, scripting, or automation within requirements tools Key Skills • Enterprise Requirements Management Tools (Codebeamer, DOORS, Jama, Polarion) • Requirements Migration & Data Integrity • Design Controls & Regulatory Compliance • Requirements Structuring & Traceability • Workflow Configuration, Versioning & Baselining • Tool Administration & Optimization • Cross-Functional Collaboration & Training Additional Details • 5+ years of relevant hands-on experience required • Onsite role in Pleasanton, CA • Interview process: Single video interview (onsite if local) If you are interested in hearing more about the position, please respond to this posting with your resume attached. Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy