Software Quality Engineer

As a Software Quality Engineer, you will be responsible for ensuring compliance with design control, risk management, usability, and software validation requirements throughout the development lifecycle of advanced ophthalmic surgical systems. You will support Design Control processes by working closely with cross-functional teams to help develop safe, effective, and regulatory-compliant software-driven medical equipment. You will provide technical guidance on software-related quality assurance, including compliance with IEC 62304 and related standards. This is a global role, with a strong focus on overseeing third-party partners involved in the design, development, and manufacturing of active surgical equipment for ophthalmic use.

Key Responsibilities

• Serve as the Quality core team member on new product development and sustaining initiatives for surgical capital equipment
• Develop, implement, and maintain QMS elements to ensure product quality throughout the lifecycle, including coordination with third-party QMS when needed
• Provide guidance on system and software design controls, validation, and verification processes
• Ensure compliance with IEC 60601 for electrical safety, electromagnetic compatibility (EMC), and essential performance
• Lead risk management activities for software in line with ISO 14971 and IEC 62304, including classification and mitigation strategies
• Guide usability engineering per EN 62366, including human factors validation and interface risk management
• Review and approve software documentation, including requirements, architecture, risk management files, and V&V plans
• Support cybersecurity risk management and ensure alignment with relevant standards
• Oversee design transfer activities to ensure software quality is preserved during manufacturing handoff
• Provide quality input into complaint analysis, nonconformances, and health hazard assessments
• Lead or support CAPA activities and use systematic problem-solving methods to resolve quality issues
• Lead internal/external audits and supplier evaluations; report on quality metrics and compliance gaps
• Collaborate with senior management and regulatory authorities as needed

Qualification

• Bachelor’s degree in Software Engineering, Biomedical Engineering, Life Sciences, or a related field
• Minimum 5 years of experience in software quality engineering within the medical device industry
• Experience with active medical devices and embedded software development is preferred
• Strong understanding of software design controls and relevant standards (IEC 62304, ISO 14971, IEC 60601)
• Familiarity with FDA, EU MDR, ISO 13485, and other applicable regulations
• Proficiency in software validation, risk management, and cybersecurity practices
• Strong analytical and problem-solving abilities
• Experience using statistical tools such as Minitab is a plus
• Excellent communication and collaboration skills
• Ability to work cross-functionally with R&D, Manufacturing, and Regulatory Affairs
• Willingness to travel occasionally for audits or supplier visits