Technical Lead - MDR, 510(k), DHF Remediation

Experience: Not Available to Not Available years

Location: Chennai, India

Skills: MDR processes, 510(K) submissions, DHF, IVDR, ISO 13485 standards, coding standards, best practices in software development, risk assessment, risk management, leadership skills, Certified Quality Engineer (CQE), Certified in Medical Device Quality (CMDQ)

Job Summary

As a Technical Lead in the MDR Development area, you will play a crucial role in managing technology within projects and delivering technical guidance that drives successful outcomes. Your expertise will not only ensure adherence to industry standards but also enhance team capabilities, fostering an environment of continuous improvement and innovation. This position is integral to advancing our commitment to quality and compliance in medical device development.

Key Responsibilities

1.

Provide Technical Guidance And Solutions By

Defining, Advocating, And Implementing Best Practices And Coding Standards In Mdr Processes, Ensuring High-Quality Outputs From The Team.

2.

Develop And Mentor Team Members To

Enhance Their Technical Capabilities In Areas Such As 510(K) Submissions And Iso 13485 Compliance,



Driving Productivity And Performance Improvements.

3.

Ensure Process Compliance In Assigned Modules

By Participating In Technical Discussions And Reviews, Acting As A Technical Consultant For Feasibility Studies And Evaluating Technical Alternatives, Best Packages, And Architecture Best Practices.

4.

Prepare And Submit Detailed Status Reports To Minimize Project Exposure And Risks, Effectively Managing Escalations And Ensuring Transparency In Project Progress.

Skill Requirements

1.

Solid Understanding Of Mdr Processes And

Related Regulatory Requirements.

- In-Depth Knowledge Of 510(K) Submissions, Dhf, Ivdr, And Iso 13485 Standards.

3.

Proficiency In Implementing Coding Standards And

Best Practices In Software Development For Medical Devices.

4.

Familiarity With Risk Assessment And Management In The Context Of Technical Projects.

5.

Excellent Communication And Leadership Skills To

Guide And Develop Team Members.

Other Requirements

1.

Optional Certifications: Certified Quality Engineer (Cqe), Certified In Medical Device Quality (Cmdq), Or Equivalent Relevant Certifications Are Valued.

📌 Technical Lead MDR, 510(k), DHF Remediation (India)
🏢 HCL Technologies
📍 India