About us : HCLTech is a global technology company, home to more than 223,400 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2023 totaled $12.8 billion. To learn how we can supercharge progress for you, visit hcltech.com. Website -
Job Description :
- Responsible for providing technical leadership in your areas of responsibility and ensuring the systems design and documentation meet all safety and regulatory compliance requirements
- Expertise in various Systems Engineering principles including user and stakeholder need definition; requirements definition; risk management, product architecture, configuration management, traceability, change management and reliability
- The candidate must have strong analytical and communication skills and should be self-driven
- Other attributes include multi-tasking, critical thinking, strong analytical, decision making and communication (spoken and written) skills
- Demonstrated scientific writing skills,
Responsibilities :
- Development of exciting new drug / device combination products for various phases of clinical studies and work closely with cross-functional teams from concept through launch
- Responsible for integration of inputs and risks from multiple functions to ensure robust patient-centric product design and performance.
Responsible to drive the following activities/deliverables :
- User and Stakeholder Needs Definition
- System Architecture & Integration
- Use Case Analysis
- Traceability
- Standards Coverage Analysis
- Risk Management Planning and reporting
- System Risk Assessment
- Use Error Risk Assessments
- System/Sub-System Requirements Definition
- Provide technical leadership in areas of responsibility and ensure the Design History File meets all regulatory compliance requirements
- Expertise in DHF management and creating various Design Control documents in compliance with regulations.
- Experience in vendor communication, deliverable acceptance testing.