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Technical Project Coordinator
2 months ago
About HCLTech: HCLTech is a prominent global technology firm, employing over 223,400 professionals across 60 nations. We excel in delivering top-tier capabilities focused on digital transformation, engineering, cloud solutions, and artificial intelligence, supported by a comprehensive range of technology services and products. Our collaborations span various industries, offering tailored solutions in Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and Consumer Packaged Goods, and Public Services.
Position Overview:
- As a Project Engineer, you will provide essential technical guidance within your designated areas, ensuring that system designs and documentation adhere to all safety and regulatory standards.
- Proficiency in Systems Engineering principles is crucial, including defining user and stakeholder needs, requirements analysis, risk management, product architecture, configuration management, traceability, change management, and reliability assurance.
- The ideal candidate will possess strong analytical and communication skills, demonstrating a self-motivated approach to their work.
- Key attributes include the ability to multi-task, critical thinking, and effective decision-making, along with excellent spoken and written communication skills.
- Demonstrated proficiency in scientific writing is essential.
Key Responsibilities:
- Drive the development of innovative drug/device combination products for various clinical study phases, collaborating closely with cross-functional teams from concept through to launch.
- Oversee the integration of inputs and risks from diverse functions to ensure a robust, patient-centered product design and performance.
Specific Deliverables:
- Definition of User and Stakeholder Needs
- System Architecture and Integration
- Use Case Analysis
- Traceability Management
- Standards Coverage Analysis
- Risk Management Planning and Reporting
- System Risk Assessment
- Use Error Risk Assessments
- System/Sub-System Requirements Definition
- Provide technical leadership in your areas of responsibility, ensuring that the Design History File complies with all regulatory requirements.
- Expertise in Design History File management and the creation of various Design Control documents in accordance with regulations.
- Experience in vendor communication and deliverable acceptance testing.