Design Quality Engineer

Responsibilities

• Provide oversight of system and hardware quality and risk management throughout the product life cycle
• Participate in the development and maintenance of software quality documentation, including Software Requirement Specifications (SRS)
• Execute assessments of software designs and review test data to ensure compliance with safety and regulatory standards
• Conduct in-depth root cause analysis for software quality issues to improve design processes
• Guide the validation of key software design inputs such as usability, reliability, performance, and safety
• Ensure effective oversight of software quality plans and risk management activities
• Utilize post-market analytics and statistics to monitor software performance in the field
• Report key software quality metrics aligned with business objectives and regulatory expectations

Requirements

• Bachelor's Degree in Engineering
• 5-6 years of experience in Software Quality Engineering or an equivalent role
• Experience in the medical device industry or another highly regulated environment
• Strong experience in design control and new product development
• Strong statistical and analytical abilities (e.g., Design for Six Sigma, Design for Reliability)
• Professional knowledge of ISO 13485, FDA 820, and ISO 14971
• Knowledge of product safety standards including IEC 60601 and IEC 62366
• Fluent English in both written and spoken communication

Benefits

• Rewarding career opportunities within a global health-tech leader
• Personal development budget, including free training and coaching
• Attractive collective health insurance package
• Opportunity to purchase Philips shares and products at a discount

About the Company

Philips is a global health-tech leader focused on improving people’s health and wellbeing through meaningful innovation. For more than 130 years, we have been creating technologies that support healthcare practitioners and improve lives across the health continuum.