Job Summary

To be responsible for managing technology in complex projects ,providing technical guidance and ensuring successful delivery of solutions. Design Control, Risk management in Lead role. (DQE preferred). Minimum Level 4+ Yrs of Experience in Design Control required. Key Responsibilities 1. Design Controls & Requirements Management Review customer, business, and regulatory requirements for clarity, completeness, consistency, and testability Ensure design inputs are defined, approved, traceable, and controlled Establish and maintain end‑to‑end traceability between requirements, design outputs, risks, and tests Participate in requirements reviews and VOC analysis 2. Risk Management & Safety Lead or support design risk management activities, including: DFMEA / FMEA Hazard analysis Use‑related risk assessments (where applicable) Ensure risks are properly mitigated and traced to design controls and verification activities Support risk‑benefit analysis and residual risk evaluation 3. Design Reviews & Design Outputs Participate in formal design reviews (Design Input, Output, Verification, Validation) Ensure design outputs (drawings, specifications, software artifacts) correctly implement design inputs Verify documentation completeness, accuracy, and version control Identify and drive closure of quality gaps and non‑conformances 4. Design Verification Review and approve design verification plans, protocols, and acceptance criteria Ensure verification activities demonstrate compliance to design inputs Track verification coverage and ensure timely closure of gaps Review verification reports and objective evidence 5. Design Validation Support design validation planning and execution Ensure validation represents intended use and user needs Review validation results, deviations, and corrective actions Confirm unresolved issues are documented and risk‑assessed 6. Design Change & Configuration Management Review and approve design changes from a quality and compliance perspective Perform or support change impact analysis Ensure re‑verification or re‑validation is triggered when required Maintain configuration control and documentation integrity 7. Regulatory Compliance & Audit Support Ensure design activities comply with applicable quality standards and regulations Support internal audits, external audits, and regulatory inspections Maintain and support Design History File (DHF) or equivalent technical documentation Participate in mock audits and compliance gap assessments 8. Cross‑Functional Collaboration Act as the quality interface between: Design Engineering Regulatory Affairs Manufacturing Testing and Program teams Provide quality guidance and training to project teams Promote a quality‑by‑design culture Required Qualifications Education Bachelor’s degree in Engineering, Quality, or a related technical field Experience Design Control, Risk management in Lead role. (DQE preferred). Minimum Level 4+ Yrs of Experience in Design Control required. Experience working in cross‑functional product development teams Exposure to regulated or high‑reliability product environments preferred Required Skills & Competencies Technical & Quality Skills Design Controls and Design Assurance Risk Management (FMEA, Hazard Analysis) Verification & Validation methodologies Requirements and traceability management Change control and configuration management Tools & Systems PLM tools (e.g., Adaptiv, Windchill etc) Document management systems Test and defect

Key Responsibilities

1. To be responsible for providing technical guidance to a team of developers, enhancing their technical capabilities and increasing productivity.
2. To conduct comprehensive code reviews, establish and oversee quality assurance processes, performance optimization , implementation of best practices and coding standards to ensure successful delivery of complex projects.
3. To ensure process compliance in the assigned module| and participate in technical discussions/review as a technical consultant for feasibility study (technical alternatives, best packages, supporting architecture best practices, technical risks, breakdown into components, estimations).
4. To collaborate with stakeholders to define project scope, objectives, deliverables and accordingly prepare and submit status reports for minimizing exposure & closure of escalations.

Skill Requirements

null

Other Requirements

null