Director, Design Assurance

Summary

12+ years of experience in medical device design, testing, quality assurance and product development, specifically in Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls), with a proven track record of leading an engineering team during internal and FDA audits within a start-up environment.

Expectations

A vibrant medical device engineering team to lead on design assurance, compliance testing, auditing and regulations.

Employment Preferences

Expected Base Salary

**0,000 USD

Expected Hourly Rate

**0 USD/hr

Academic Degree

Experience

Skills

• Medical Device Design
• Design Assurance
• Quality Assurance
• Product Management
• CAPA
• Failure Analysis
• Medical Device Regulations
• ISO 13485
• ISO 14971
• IEC 62304
• 21 CFR Part 820.30
• FDA Audits
• Class 2
• Class 3
• Compliance Testing