ALM Engineer/ Requirements Tools Engineer

Job Title: ALM Engineer/ Requirements Tools Engineer
Location: 6035 Stoneridge Drive, Pleasanton, CA 94588
Duration: 12 Months
Work Arrangement: 100% Onsite
Pay Range: $65 - $70 per hour (W2)

We are seeking a “ALM Engineer/ Requirements Tools Engineer” to join one of our leading healthcare clients.

Position Overview
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.

• 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.

• 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.

• Develop scripts and automation solutions as needed.
• Support integrations and add-on tools to improve efficiency and usability.
• Optimize requirements management processes and workflows.

• 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.

• Bachelor's Degree in:
  • Engineering
  • Computer Science
  • Biomedical Engineering
  • Related technical discipline

• 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.

• 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.

• Codebeamer
• IBM DOORS
• Jama
• Requirements hierarchy management
• Workflow configuration
• Versioning
• Baselining

• Migration from:
  • DOORS
  • Jama
  • Excel
  • Jira
• Data validation
• Traceability preservation
• Compliance management

• Medical device development lifecycle
• Design controls
• Quality systems
• FDA-regulated environments
• Compliance-focused tool configuration

• Requirements architecture
• Traceability frameworks
• Governance models
• Standardized templates
• Multi-team requirements management

We are looking for the candidate who are eligible to work with any employers without sponsorship.

If you’re interested, please click “Apply” button.