Design Lead - MDR k), DHF Remediation

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

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:

• Prepare and Review Design History File (DHF) documents of new orthopedic instruments and routing it in the Customer PLM as per project timeline.
• Convert Surgeon's instrument request to feasible user requirements for concept generation by understanding the request and getting inputs from various stake holders like Regulatory and Microbiology team.
• Create CAD models and drawings against customer procedure, Tolerance stack up analysis, overlay or layout required for Design Verification.
• Review medical device risk management documents including Risk Management Plan, Preliminary Hazard Analysis, Design and Failure Mode and Cause Analysis, Risk Assessment Summary and Risk Assessment Report for new orthopedic instruments.
• Prepare Design Verification and Validation Test Protocols and Reports to test the instrument design in the lab setup.
• Co-ordinate with cross functional teams.

Skill Requirements:

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

Other Requirements:

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

Maximum Salary (US): 118000 Minimum Salary (US): 77000