Design Quality Engineer – New Product Development

About the role

We are looking for a Design Quality Engineer to join our cross‑functional new product development team in Alajuela. You will ensure that design controls are robust, compliant with regulations and company policies, and that products reach the market safely and effectively.

Key responsibilities

• Lead risk management planning, conduct design FMEA, and verify risk mitigation effectiveness.
• Drive quality design transfer activities, including test method validation, measurement systems analysis and incoming inspection.
• Support process validations, master validation plans, and process FMEA.
• Develop and release engineering design documentation, assist in design reviews and compile the Design History File.
• Provide quality input for product user needs, design inputs, specifications and outputs, focusing on critical‑to‑quality features.
• Support design verification, validation and usability testing, and prepare regulatory submissions.
• Conduct design control gap assessments and participate in internal and external audits.
• Identify and implement cross‑functional process improvement initiatives.

Required profile

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 2 years experience in the medical‑device or other regulated industry.
• Fluent English (C1) – written and spoken.
• Knowledge of FDA QSR, ISO 13485 and ISO 14971.

Required skills

• Risk Management
• Design Failure Mode Effects Analysis (FMEA)
• Measurement Systems Analysis
• Design Verification and Validation
• Usability Testing
• FDA QSR
• ISO 13485
• ISO 14971

What we offer

• Hybrid work model with flexible schedules.
• Stock purchase program, referral bonus and transport/food subsidies.
• Extra days off, birthday off and voluntary hours.
• Medical insurance, company doctor, gym access and employee assistance program.
• Continuous learning opportunities and training programs.