[Hiring] Software Systems & Requirements Engineering Manager @GlobalLogic

Role Description

The Software Systems & Requirements Engineering Manager will lead requirements engineering and software lifecycle remediation activities for regulated medical devices. This person will be responsible for:

• Assessing the existing requirements baseline
• Identifying gaps and inconsistencies
• Defining a remediation strategy
• Ensuring complete bidirectional traceability throughout the software development lifecycle

The role requires a combination of medical-device domain expertise, strong systems and requirements engineering capabilities, technical leadership, and experience working with legacy products and documentation. The manager will work closely with the customer's Systems Engineering, Software Engineering, Software Quality Assurance, Regulatory Affairs, Risk Management, and Verification and Validation teams.

Qualifications

• Bachelor's or Master's degree in Systems Engineering, Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, or a related technical discipline
• Significant professional experience in systems engineering, software requirements engineering, or software lifecycle management
• Experience leading requirements engineering activities or multidisciplinary engineering teams
• Strong experience with regulated medical-device software
• Demonstrated experience working with software Design History Files
• Hands-on experience with requirements gap analysis and legacy software remediation
• Strong understanding of system and software requirements development, decomposition, review, approval, and change control
• Experience establishing end-to-end and bidirectional requirements traceability
• Experience connecting requirements with hazards, risk controls, software design, verification evidence, and defects
• Strong understanding of medical-device design controls and software lifecycle documentation
• Experience preparing technical documentation for design reviews, audits, or regulatory submissions
• Strong analytical and problem-solving skills
• Excellent written and verbal English communication skills
• Ability to work effectively with engineering, quality, regulatory, and business stakeholders

Requirements

• Practical knowledge of several of the following:
• IEC 62304 - medical-device software lifecycle processes
• ISO 13485 - medical-device quality management systems
• ISO 14971 - medical-device risk management
• FDA Design Controls
• FDA 21 CFR Part 820
• FDA guidance applicable to medical-device software
• IEC 62366-1 - usability engineering
• Cybersecurity requirements applicable to connected medical devices
• Software verification and validation practices
• Design change control and configuration management

Job Responsibilities

• Lead the assessment and remediation of existing system and software requirements for regulated medical devices
• Define and execute the requirements and traceability remediation strategy
• Review existing software Design History File documentation and identify missing, incomplete, inconsistent, or obsolete artifacts
• Identify gaps between intended product behavior, existing implementation, system requirements, software requirements, risk controls, and verification evidence
• Establish and maintain complete bidirectional traceability between:
• User and stakeholder needs
• System requirements
• Software requirements
• Software architecture and detailed design
• Hazards and software-related risks
• Risk-control measures
• Verification and validation test cases
• Defects, deviations, and change requests
• Lead the creation, clarification, decomposition, and improvement of system and software requirements
• Ensure requirements are clear, testable, unambiguous, consistent, feasible, uniquely identified, and traceable
• Define requirements attributes, review criteria, traceability rules, and approval workflows
• Coordinate requirements reviews with software, systems, quality, regulatory, clinical, and test stakeholders
• Ensure risk-control requirements are properly represented in the requirements baseline and verified through objective evidence
• Support the reconstruction and maintenance of requirements traceability matrices
• Ensure that DHF documentation is complete, internally consistent, audit-ready, and aligned with actual product implementation
• Lead impact analysis for requirements changes, defects, anomalies, and product updates
• Support investigation and resolution of discrepancies between documented requirements and existing software behavior
• Collaborate with verification teams to identify missing or insufficient test coverage
• Ensure that verification results provide adequate evidence for applicable system and software requirements
• Define and track remediation metrics, priorities, dependencies, risks, and completion status
• Provide technical direction and mentoring to systems and requirements engineers
• Coordinate work across customer and distributed engineering teams
• Communicate documentation risks, compliance gaps, project status, and remediation progress to engineering and quality leadership
• Support internal and external audits and provide technical explanations of the requirements and traceability approach
• Contribute to improvements in requirements engineering, change control, risk management, and software lifecycle processes

Benefits

• Empowering Projects: Contribute to groundbreaking projects that leverage cutting-edge technologies
• Empowering Growth: Continuous learning and professional development opportunities
• DE&I Matters: Commitment to diversity and equal opportunities
• Career Development: Strong emphasis on career development and recognition
• Comprehensive Benefits: A benefits package prioritizing overall well-being
• Flexible Opportunities: Work-life balance with flexible opportunities

Company Description

GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world's largest and most forward-thinking companies. Since 2000, we've been at the forefront of the digital revolution - helping create some of the most innovative and widely used digital products and experiences.