Project Manager

Experience: Not Available to Not Available years

Location: Chennai, India

Skills: Design Verification, Validation (V&V;), protocol development, gap analysis, MDR Article 22 remediation, technical documentation, labels, IFUs, DHF remediation, design control, regulatory requirements, risk management, ISO 14971, FMEA, Hazard Analysis, Use‑Error Analysis, process validation, IQ/OQ/PQ, remediation of validation plans, remediation of protocols, test methods, statistical analysis, DOE, capability studies, sampling plans, Minitab, project management, cross‑functional approvals, failure investigation, root cause analysis, CAPA activities, leadership

Job Summary
To manage and ensure that the project schedules are adhered to as per the client specifications and deliveries are as per the time and quality standards. Perform Design Verification & Validation (V&V;) activities including protocol development, execution, gap analysis, and documentation. Conduct MDR Article 22 remediation, creation of technical documentation, labels, and IFUs. Execute DHF remediation, aligning legacy files with current design control and regulatory requirements. Support risk management in accordance with ISO 14971 (FMEA, Hazard Analysis, Use‑Error Analysis). Lead process validation activities (IQ/OQ/PQ), including remediation of validation plans and protocols. Develop and qualify test methods following industry standards. Support engineering change management by assessing technical impact, documentation updates, and cross‑functional approvals. Perform failure investigation,



root cause analysis, and support CAPA activities. Conduct statistical analysis (DOE, capability studies, sampling plans) using Minitab. Monitor and report the status of key projects, highlighting risks and impacts. Communicate updates to senior leaders in a transparent and concise manner. Organize and lead weekly leadership meetings, setting agendas with project leads. Review and share important information with business leaders. Collaborate with global teams to manage project progress. Lead and support technical and cross-functional project execution. Ensure product quality, regulatory compliance, and supply continuity. Implement and maintain product development processes and design controls.

Key Responsibilities
1. To oversee quality assurance processes, ensuring adherence to coding standards, implementation of best practices and perform Value creation and KM activities.
2. To ensure process improvement and compliance and participate in technical design discussion and to review technical documents.
3. To create project plans and keep track of schedule for on time delivery as per the defined quality standards.
4. To work closely with the development team, On-site Engineers to understand technical requirements and work with them to address and resolve technical issues.
5. Identify & flag potential risks and issues that may impact project timelines or quality, develop mitigation strategies / contingency plans to address risks and provide regular project updates to key stakeholders.

Other Requirements
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📌 Project Manager (Chennai)
🏢 HCL Technologies
📍 Chennai