Requirements Tools Engineer

Job Title: Requirements Tools Engineer Location: 6035 Stoneridge Drive, Pleasanton, CA 94588 Duration: 12 Months Work Arrangement: 100% Onsite Position Overview Abbott's Heart Failure Division is seeking a Requirements Tools Engineer to support medical device product development by enabling, administering, and maintaining enterprise requirements management infrastructure. This role focuses on configuring and optimizing requirements management tools, supporting requirements migration from legacy systems, maintaining traceability and compliance, and enabling engineering teams through training, governance, and process support. The successful candidate will work closely with cross-functional engineering teams to establish scalable requirements structures, workflows, templates, and best practices that support compliant medical device development. Key Responsibilities Requirements Management Tools Administration • Administer, configure, and maintain enterprise requirements management platforms. • Configure and manage: • Requirements hierarchies • Templates • Workflows • Versioning • Baselining • Ensure tool configurations align with quality system requirements. Requirements Migration & Data Management • Plan and execute migration of requirements and related artifacts from legacy systems such as: • DOORS • Jama • Excel • Jira • Maintain: • Data integrity • Traceability • Regulatory compliance • Support requirements database administration and maintenance. Requirements Framework & Governance • Develop and maintain requirements management plans. • Define scalable requirements structures across development programs. • Establish: • Standardized templates • Traceability frameworks • Governance models • Link requirements to associated design control documentation. Automation & Tool Enhancements • Develop scripts and automation solutions as needed. • Support integrations and add-on tools to improve efficiency and usability. • Optimize requirements management processes and workflows. Training & Support • Serve as the primary subject matter expert for requirements management tools. • Provide: • User training • Documentation • Ongoing support • Guide engineering teams on best practices for requirements management and traceability. Required Qualifications Education • Bachelor's Degree in: • Engineering • Computer Science • Biomedical Engineering • Related technical discipline Experience • Minimum 5 years of hands-on experience administering or configuring enterprise requirements management tools in regulated development environments. • Experience with tools such as: • Codebeamer • IBM DOORS • Jama • Similar requirements management platforms • Hands-on experience performing requirements migration from legacy systems. • Strong understanding of: • Medical device product development • Design control processes • Requirements traceability • Excellent verbal and written communication skills. • Ability to train and support engineering teams. • Strong collaboration and cross-functional communication skills. Preferred Qualifications • Experience serving as: • Tool Administrator • Configuration Owner • Advanced Power User • Experience building or scaling requirements management frameworks for large or multi-team programs. • Familiarity with: • FDA 21 CFR Part 820 • Medical device quality systems • Regulatory compliance workflows • Experience supporting: • Software-driven medical devices • Connected medical devices • Mobile medical device platforms • Experience with multiple requirements management and lifecycle management tools. Top 4 Required Skills • Enterprise Requirements Management Tools • Codebeamer • IBM DOORS • Jama • Requirements hierarchy management • Workflow configuration • Versioning • Baselining • Requirements Migration & Data Integrity • Migration from: • DOORS • Jama • Excel • Jira • Data validation • Traceability preservation • Compliance management • Design Controls & Regulatory Compliance • Medical device development lifecycle • Design controls • Quality systems • FDA-regulated environments • Compliance-focused tool configuration • Requirements Structuring & Traceability • Requirements architecture • Traceability frameworks • Governance models • Standardized templates • Multi-team requirements management Consultants Eligible Benefits Upon Waiting Period • Medical and Prescription Drug Plans • Dental Plan • Vision Plan • Health Savings Account (for High Deductible Health Plans) • Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit) • Supplemental Life Insurance • Short Term Disability (coverage varies by state) • Long Term Disability • Critical Illness, Hospital coverage, Accident Insurance • MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance • 401(k) Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.