Job Summary

Job Purpose: The Design Lead - MDR plays a critical role in overseeing the design team responsible for Medical Device Reporting (MDR). This position requires setting design standards, contributing to the design strategy, and collaborating with various stakeholders to ensure that design efforts are effectively aligned with business objectives. The Design Lead will serve as a bridge between design and business, driving innovation while ensuring compliance with regulatory standards.

 

Key Responsibilities: 1. Collaborate With Key Stakeholders To Understand Business Objectives And Integrate Design Thinking Into The Development Of Medical Devices In Accordance With Mdr Guidelines.
2. Lead A Team Of Designers, Providing Guidance And Mentorship While Ensuring The Delivery Of High-Quality Design Solutions That Comply With Iso 13485 Standards And Align With Business Goals.
3. Present Design Concepts And Strategies To Stakeholders, Gathering And Incorporating Feedback To Refine Product Designs And Ensure Regulatory Compliance.
4. Establish And Maintain Design Standards, Guidelines, And Best Practices Specific To Mdr, Ensuring Consistency And Quality Across All Design Projects.
5. Monitor Industry Trends And Emerging Technologies In Medical Device Design To Drive Innovation And Excellence, Adapting Design Strategies To Meet Evolving Regulatory Requirements Such As 510(K) And Ivdr.<b>

Skill Requirements: 1. In-Depth Understanding Of Medical Device Reporting (Mdr) Regulations And Standards.
2. Solid Experience With Iso 13485 And Its Application In Design Processes.
3. Strong Proficiency In Design Thinking Methodologies And User-Centered Design Principles.
4. Excellent Communication And Presentation Skills To Effectively Articulate Design Concepts To Stakeholders.
5. Familiarity With Regulatory Submissions Including 510(K) And Ivdr.

Other Requirements: 1. Certification In Ux Design Or Human Factors Engineering Is Optional But Valuable.
2. Relevant Training Or Certification In Iso 13485 Is Advantageous.

Key Responsibilities

1. Collaborate With Key Stakeholders To Understand Business Objectives And Integrate Design Thinking Into The Development Of Medical Devices In Accordance With Mdr Guidelines.
2. Lead A Team Of Designers, Providing Guidance And Mentorship While Ensuring The Delivery Of High-Quality Design Solutions That Comply With Iso 13485 Standards And Align With Business Goals.
3. Present Design Concepts And Strategies To Stakeholders, Gathering And Incorporating Feedback To Refine Product Designs And Ensure Regulatory Compliance.
4. Establish And Maintain Design Standards, Guidelines, And Best Practices Specific To Mdr, Ensuring Consistency And Quality Across All Design Projects.
5. Monitor Industry Trends And Emerging Technologies In Medical Device Design To Drive Innovation And Excellence, Adapting Design Strategies To Meet Evolving Regulatory Requirements Such As 510(K) And Ivdr.

Skill Requirements

1. In-Depth Understanding Of Medical Device Reporting (Mdr) Regulations And Standards.
2. Solid Experience With Iso 13485 And Its Application In Design Processes.
3. Strong Proficiency In Design Thinking Methodologies And User-Centered Design Principles.
4. Excellent Communication And Presentation Skills To Effectively Articulate Design Concepts To Stakeholders.
5. Familiarity With Regulatory Submissions Including 510(K) And Ivdr.

Other Requirements

1. Certification In Ux Design Or Human Factors Engineering Is Optional But Valuable.
2. Relevant Training Or Certification In Iso 13485 Is Advantageous.