Senior Design Lead - MDR, 510(k), DHF Remediation

Experience: Not Available to Not Available years

Location: Chennai, India

Skills: MDR standards, regulatory requirements, user-centered design principles, usability testing, design thinking methodologies, Sketch, Adobe Creative Suite, Figma, ISO 13485, human factors engineering, design for medical devices

Job Summary
The Senior Design Lead is pivotal in shaping and overseeing the design direction for multiple projects within the Medical Device Regulations (MDR) landscape. This role emphasizes the importance of user-centric design while ensuring adherence to regulatory standards. The Senior Design Lead will drive innovation, set organizational design standards, and foster collaboration within design teams to achieve strategic business objectives.

Key Responsibilities
1. Leverage Design Expertise In Mdr To Create User-Friendly And Intuitive Software And Products That Comply With Regulatory Requirements, Contributing To Seamless User Experiences And Enhancing Customer Satisfaction.
2. Lead And Mentor A Team Of Designers, Providing Guidance On Best Practices In Design Methodologies And Ensuring The Delivery Of High-Quality Design Solutions That Align With Business Goals And Regulatory Standards.
3. Present Design Concepts Effectively To Stakeholders,



Playing A Crucial Role In Shaping The Design Vision And Strategy While Ensuring Alignment With Mdr Compliance And Organizational Objectives.
4. Stay Abreast Of Industry Trends, Emerging Technologies, And Regulatory Changes, Driving Innovation And Excellence In Design Practices Within The Mdr Framework.
5. Collaborate With Cross-Functional Teams, Including Engineering And Compliance, To Ensure That Design Processes Are Integrated With Product Development And Adhere To Iso 13485 Standards.
6. Conduct User Research And Usability Testing To Gather Insights That Inform Design Decisions And Validate Design Solutions Against User And Regulatory Expectations.

Skill Requirements
1. Advanced Proficiency In Mdr Standards And Processes, With A Strong Understanding Of Regulatory Requirements Related To Medical Device Design.
2. Solid Experience In User-Centered Design Principles, Usability Testing, And Design Thinking Methodologies.
3. Excellent Skills In Design Tools And Technologies, Such As Sketch, Adobe Creative Suite, Or Figma.
4. Robust Understanding Of Iso 13485 And Its Impact On The Design Process In Medical Devices.
5. In-Depth Knowledge Of Emerging Technologies And Design Trends Relevant To The Healthcare Sector.

Other Requirements
1. Certification In Human Factors Engineering (Hfes) Or Design For Medical Devices Is Optional But Valuable.
2. Relevant Certifications In Iso Standards Or Medical Device Design Processes Are Highly Recommended.

📌 Senior Design Lead MDR, 510(k), DHF Remediation (Chennai)
🏢 HCL Technologies
📍 Chennai