Arevna Sheffield, England, United Kingdom
Design Assurance Engineer
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
Seniority level
Not Applicable
Employment type
Full-time
Industries
Medical Equipment Manufacturing
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