Design Quality Assurance Engineer

About the role

Establishment Labs is seeking a Design Quality Assurance Engineer to join its fast‑growing medical‑device team. In this role you will apply design‑control, human‑factors, risk‑management and quality‑engineering expertise to ensure new products and design changes meet regulatory, customer and industry standards.

Key responsibilities

• Support the design‑controls process for new devices and design changes, including planning, requirements, validation, verification and design transfer.
• Lead root‑cause investigations and corrective‑action activities related to design issues.
• Drive Usability Engineering activities: strategy planning, formative and summative evaluations, and reporting.
• Review and approve engineering documentation such as design deliverables, CAPAs, non‑conformances and critical control points.
• Coordinate creation, review and updates of risk‑management files and reports in partnership with Operations Quality and Quality System teams.
• Apply company policies and procedures and perform any additional functions assigned by management.

Required profile

• Bachelor’s degree in Industrial, Biomedical, Mechanical, Chemical or Materials Engineering.
• Minimum 2 years of experience in a medical‑device quality environment.
• Intermediate proficiency in written and spoken English.
• Strong team player with excellent communication and analytical thinking abilities.

Required skills

• Design controls
• Human factors engineering
• Risk management
• Quality engineering techniques
• Usability engineering