Senior Technical Lead

Experience: 5 to Not Available years

Location: Chennai, India

Skills: Mechanical engineering, Design control, Project management, Design change controls, Design reviews, Design transfer, 21 CFR Part 820.30, ISO 13485, ISO 14971, Design verification protocols, Engineering first principles, Advanced engineering methods

Job Summary
To be responsible for managing technology in complex projects, providing technical guidance and ensuring successful delivery of solutions. JD for E2 band: Mechanical engineer with rich experience on design control and project management experience. Candidate need to get up to speed quickly, be able to work independently and drive teams toward on-time completion.

Job Description:
• Mechanical engineer with a 5+ years design control and project management experience.
• Proven ability to lead multiple / complex sustenance engineering projects and lead the cross-functional teams (i.e., R&D;, Marketing, Quality, Regulatory, Manufacturing, Operations, Medical Affairs etc.) to deliver the design solutions.
• Experience in contributing/leading Design change controls, Design reviews and Design transfer.
• Robust written and verbal communications skills. Ability to write and independently analyze results of technical reports.
• Knowledge of the following standards: 21 CFR Part 820.30, ISO 13485, and ISO 14971.
• Development and release of design control documentation. Lead appropriate documentation of activities in accordance with existing policies and procedures (Divisions, Corporate,



and Regulatory compliance).
• Lead creation and execution of Design verification protocols, summarize results, enable formal design reviews and own the verification portion of the Design History File.
• Application of engineering first principles and advanced engineering methods to gain deep understanding of the underlying technical issues, and to propose and implement robust solutions.
• Optimize product design, material selection, product features, process design and human factor needs based on the project needs.
• Coach and mentor junior engineers and technicians to execute project deliverables.

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.

📌 Senior Technical Lead (Chennai)
🏢 HCL Technologies
📍 Chennai