Design Quality Engineer – Medical Devices

About the role

The Design Quality Engineer will support the quality, reliability and safety of medical devices throughout all lifecycle phases. You will help achieve quality objectives such as customer experience, complaint rate, and first‑pass yield while representing design quality in new development programs.

Key responsibilities

• Represent design quality during new development programs and sustaining activities, interfacing with regulatory affairs.
• Provide independent oversight of product performance related to quality, safety and reliability.
• Participate in establishing quality and reliability strategy, set quality targets in the Project Charter, and define the Product Quality Plan.
• Review reliability plans, key quality requirements, and ensure proper transfer of design specifications to manufacturing and supply chain.
• Apply and facilitate Design for Quality & Reliability best practices such as FMEA, robust design, verification & validation, and root‑cause analysis.
• Lead problem‑solving activities, conduct root‑cause investigations, and drive corrective actions to prevent recurrence.

Required profile

• 5+ years of experience in the healthcare/medical‑device industry.
• Bachelor’s or Master’s degree in Mechanical Engineering, Electronics Engineering, Science or a related field.
• ASQ CQE or CQM certification preferred; ISO 13485 auditor preferred.
• High‑level English proficiency with strong written communication skills.

Required skills

• Validation of design inputs such as usability, reliability, performance, manufacturability, safety and sustainability.
• Experience with FMEA, robust design, verification & validation, and root‑cause analysis.
• Knowledge of Design for Reliability, Design for Six Sigma, statistical analysis and predictive reliability modelling.