Design Assurance Engineer

We're Hiring: Design Assurance Engineer – Medical Devices

Arevna is looking for a Design Assurance Engineer to join an innovative medical device company. This role will be instrumental in ensuring quality, compliance, and regulatory standards while collaborating with R&D, Quality, and Manufacturing teams.

Key Responsibilities:

• Represent Quality Assurance and Regulatory in new product development
• Ensure design and production meet global regulatory standards
• Work with R&D on product verification, validation, and risk management
• Lead design control activities and maintain Design History Files (DHF)
• Support manufacturing transfers and design for manufacturability
• Drive continuous improvement in compliance with ISO 13485

Ideal Candidate:

• Engineering degree or equivalent experience
• 5+ years in medical device design and development
• Strong leadership in cross-functional teams
• Expertise in risk management (FMEA, FTA) and design verification
• Proficiency in 3D CAD and design methodologies