職種概要
Project Overview
The customer is a global medical device company developing point-of-care diagnostic systems used in hospital and clinical environments.
The project focuses on the remediation and modernization of software Design History Files for an established product family. The primary objective is to improve software and system requirements, close documentation gaps, and rebuild complete end-to-end traceability across requirements, risk controls, software design, implementation, and verification evidence.
We are looking for an experienced Software Systems & Requirements Engineering Manager who will provide technical and organizational leadership for this initiative and coordinate the work of systems, software, quality, regulatory, and verification teams.
Role Overview
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, and 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.
必要条件
Required 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.
Regulatory and Standards Experience
- The candidate should have 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.
職務内容
Key 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.
私たちが提供するもの
Empowering Projects: With 500+ clients spanning diverse industries and domains, we provide an exciting opportunity to contribute to groundbreaking projects that leverage cutting-edge technologies. As a team, we engineer digital products that positively impact people’s lives.
Empowering Growth: We foster a culture of continuous learning and professional development. Our dedication is to provide timely and comprehensive assistance for every consultant through our dedicated Learning & Development team, ensuring their continuous growth and success.
DE&I Matters: At GlobalLogic, we deeply value and embrace diversity. We are dedicated to providing equal opportunities for all individuals, fostering an inclusive and empowering work environment.
Career Development: Our corporate culture places a strong emphasis on career development, offering abundant opportunities for growth. Regular interactions with our teams ensure their engagement, motivation, and recognition. We empower our team members to pursue their career goals with confidence and enthusiasm.
Comprehensive Benefits: In addition to equitable compensation, we provide a comprehensive benefits package that prioritizes the overall well-being of our consultants. We genuinely care about their health and strive to create a positive work environment.
Flexible Opportunities: At GlobalLogic, we prioritize work-life balance by offering flexible opportunities tailored to your lifestyle. Explore relocation and rotation options for diverse cultural and professional experiences in different countries with our company.
GlobalLogicについて
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. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.
