Job Description
Title: Requirements Tools Engineer
Location: Pleasanton, CA 94588
Duration: 12 Months
WHAT YOU LL DO
RESPONSIBILITIES:
REQUIRED QUALIFICATIONS:
PREFERRED QUALIFICATIONS:
Location: Pleasanton, CA 94588
Duration: 12 Months
WHAT YOU LL DO
- The Requirements Tools Engineer will be responsible for enabling and supporting requirements management infrastructure for medical device product development programs. This role is focused on administering and configuring enterprise requirements management platforms, supporting data migration activities, and enabling engineering teams through processes, and training.
- Working in Pleasanton, CA, this individual will collaborate with cross functional engineering teams to establish scalable structures and best practices that allow engineers to efficiently create and manage requirements and other design control documents in the management tool.
RESPONSIBILITIES:
- Plan and execute migration of requirements and related data from legacy tools (e.G., DOORS, Jama, Excel, Jira) into new platforms, ensuring data integrity, traceability, and compliance.
- Administer, configure, and maintain enterprise requirements management tools, including hierarchies, templates, workflows, versioning, and baselining in alignment with the quality system.
- Develop and maintain a requirements management plan in collaboration with cross functional teams, defining the overall requirements structure and links to associated design control documents.
- Create and maintain standardized requirements templates, traceability frameworks, and governance models based on quality and regulatory requirements.
- Maintain the requirements database, develop scripts or automation as needed, and support integrations or add in tools to improve usability and efficiency.
- Provide training, documentation, and ongoing support to engineers, serving as the primary functional expert for requirements tools and best practices.
REQUIRED QUALIFICATIONS:
- Bachelor s degree in Engineering, Computer Science, Biomedical Engineering, or a related discipline for requirements management.
- A minimum of 5 years with hands on experience administering or configuring enterprise requirements management tools to support regulated development environments (e.G., Codebeamer, DOORS, Jama, or comparable platforms). Ability to quickly learn and adopt new tools is expected.
- Hands on experience with requirements migration from legacy tools.
- Strong understanding of medical device product development and design control principles.
- Excellent verbal and written communication skills, with the ability to train and support engineers at all levels.
- Ability to work effectively in a collaborative environment.
PREFERRED QUALIFICATIONS:
- Experience acting as a tool administrator, configuration owner, or advanced power user in a regulated development environment.
- Experience defining or scaling requirements management frameworks for large or multi team programs.
- Familiarity with medical device development (FDA 21 CFR Part 820) with the ability to configure tools to support compliant workflows.
- Experience supporting software driven, connected, or mobile medical devices.
- Experience with different requirements management or lifecycle tools is valued;strong foundational understanding of requirements structures and traceability is more important than experience with a specific platform.
Numbers & Facts
| Location | Pleasanton, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $55 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Atlassian JIRAunmatched
- Automationunmatched
- Best Practicesunmatched
- Biomedical Engineeringunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Computer Scienceunmatched
- Cross-Functionalunmatched
- Data Migrationunmatched
- Data Qualityunmatched
- Database Administrationunmatched
- Database Programmingunmatched
- Design Documentunmatched
- Document Managementunmatched
- FDA (Food and Drug Administration)unmatched
- Medical Equipmentunmatched
- Medical Productsunmatched
- Mobile Devicesunmatched
- Presentation/Verbal Skillsunmatched
- Product Designunmatched
- Product Developmentunmatched
- Regulatory Requirementsunmatched
- Requirements Managementunmatched
- Scripting (Scripting Languages)unmatched
- Software Administrationunmatched
- Standards Developmentunmatched
- Support Documentationunmatched
- System Migrationunmatched
- Team Playerunmatched
- Technical Supportunmatched
- Traceabilityunmatched
- Training/Teachingunmatched
- Usability Engineeringunmatched
- Writing Skillsunmatched
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