Design Assurance Engineer 3 (Costa Rica)

About the role

We are seeking an experienced Design Assurance Engineer to support medical device quality, compliance, and safety throughout the product lifecycle. The role involves applying design controls, risk management, and regulatory knowledge to ensure products meet stringent standards from development through post‑market activities.

Key responsibilities

• Apply design controls for manufacturing and design changes.
• Implement and maintain risk management across the device lifecycle.
• Support internal and external audits, CAPA, NCE, SSE, QPL, complaint investigations, and post‑market surveillance.
• Develop and validate test methods, conduct root‑cause failure analysis, and use statistical methods and design of experiments.
• Perform health risk assessments for on‑market products and risk assessments for new developments.

Required profile

• Extensive knowledge of medical device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDD, EU MDR).
• Strong written and verbal English communication skills.
• Ability to work independently and lead critical tasks within multifunctional teams.
• Analytical mindset with creativity and strategic thinking.

Required skills

• Design controls
• Risk management
• FDA 21 CFR 820 compliance
• ISO 13485
• ISO 14971
• EU MDD 93/42/EEC and EU MDR 2017/745
• Good Laboratory Practices
• Verification and validation
• Test method development and validation
• Root‑cause failure analysis
• Statistical methods
• Design of experiments
• Deming Cycle / PDCA principles