Senior Quality Engineer

Summary

Join Sword Health, a Forbes Best Startup Employer, as a Senior Quality Engineer specializing in AI/ML. This fully remote role (Portugal residents only) is crucial for ensuring the safety and effectiveness of our AI-powered SaMD products. You will be responsible for quality assurance, regulatory compliance, risk management, verification and validation, documentation, training, and continuous improvement of our AI/ML software. Work alongside a talented team and contribute to building a pain-free world. Sword Health offers a competitive salary, flexible work arrangements, and various benefits.

Requirements

• Bachelor's degree in or advanced degree in Computer Science, Engineering, or related field
• 4+ years of experience in Quality Software Engineering or a related role within the medical device industry
• Proven experience with AI/ML-enabled SaMD development and quality assurance
• Strong understanding of AI/ML lifecycle processes, including data management, algorithm training, model validation, CI/CD pipeline, DevOps for automated testing and Predetermined Change Control Plan (PCCP)
• Hands-on experience with regulatory requirements for AI/ML-enabled medical devices: FDA, EU AI Act, and Health Canada regulations
• IEC 62304, BS/AAMI 34971, ISO 14971, ISO 42001, and AAMI CR 34971
• Good Machine Learning Practices (GMLP)
• Cybersecurity requirements for medical software
• Proficiency in risk management methodologies, including FMEA for AI/ML systems
• Project & Process Management: Ability to drive process improvements
• Excellent documentation skills and attention to detail
• Familiarity with software tools like Jira, Confluence, and version control systems
• Strong analytical and problem-solving skills
• Effective communication and collaboration abilities
• Fluent in English

Responsibilities

• Develop, implement, and maintain the quality management system for AI/ML-enabled SaMD, ensuring compliance with internal QMS procedures and external regulations (FDA, EU AI Act, Health Canada, etc.)
• Guide AI/ML development teams on quality processes, conduct reviews of engineering activities, and oversee model retraining and updates
• Interpret and implement relevant regulatory guidance and regulations (FDA, EU AI Act, Health Canada, ISO 13485, ISO 42001, BS/AAMI 34971, IEC 62304, IEC 81001-5-1, AAMI CR34971) to ensure AI/ML software meets all applicable requirements for safety, performance, and cybersecurity
• Act as the AI subject matter expert during audits and inspections from Health Authorities
• Lead AI-specific risk assessments, including bias, algorithmic drift, and security vulnerabilities, in accordance with BS/AAMI 34971 and ISO 14971
• Develop and maintain AI/ML risk management files and collaborate with teams to implement effective mitigation strategies
• Plan, coordinate, and execute AI/ML software verification and validation activities
• Develop robust testing strategies to evaluate model accuracy, robustness, and performance, including establishing AI-specific validation frameworks for model updates and retraining
• Create, update, and maintain comprehensive documentation related to AI/ML development, risk management, V&V, and regulatory compliance
• Establish and improve processes for maintaining traceability between AI/ML models, datasets, and associated documentation, including predetermined change control plans
• Provide training to internal teams on AI/ML-specific quality and regulatory requirements
• Collaborate effectively with cross-functional teams (AI/ML engineers, product managers, regulatory experts) and serve as a subject matter expert on AI/ML quality processes and compliance
• Lead continuous improvement initiatives to enhance AI/ML development and quality processes
• Stay updated on emerging regulatory trends and technological advancements in AI/ML

Benefits

• A stimulating, fast-paced environment with lots of room for creativity
• A bright future at a promising high-tech startup company
• Career development and growth, with a competitive salary
• The opportunity to work with a talented team and to add real value to an innovative solution with the potential to change the future of healthcare
• A flexible environment where you can control your hours (remotely) with unlimited vacation
• Access to our health and well-being program (digital therapist sessions)
• Remote or Hybrid work policy
• Health, dental and vision insurance
• Meal allowance
• Equity shares
• Remote work allowance
• Flexible working hours
• Work from home
• Unlimited vacation
• Snacks and beverages
• English class
• Unlimited access to our Learning Platform