Senior Quality Engineer - Artificial Intelligence

Sword Health is on a mission to free two billion people from pain as the world’s first and only end-to-end platform to predict, prevent and treat pain. 

With 67% of members achieving a pain-free life and a 70% reduction in surgery intent, at Sword, we are using technology to save millions for our 25,000 enterprise clients across three continents. Today, we hold the majority of industry patents, win 70% of competitive evaluations, and have raised more than $300 million from top venture firms like Founders Fund, Sapphire Ventures, General Catalyst, and Khosla Ventures.

Recognized as a Forbes Best Startup Employer in 2024, this award highlights our focus on being a destination for the best and brightest  talent. Not only have we experienced unprecedented growth since our market debut in 2020,  but we’ve also created a remarkable mission and value-driven environment that is loved by our growing team. With a recent valuation of $3 billion, we are in a phase of hyper growth and expansion, and we’re looking for individuals with passion, commitment, and energy to help us scale our impact. 

Joining Sword Health means committing to a set of core values, chief amongst them to “do it for the patients” every day, and to always “deliver more than expected” on behalf of our members and clients.

This is an opportunity for you to make a significant difference on a massive scale as you work alongside 900+ (and growing!) talented colleagues, spanning three continents. Your charge? To help us build a pain-free world, powered by technology, enhanced by people — accessible to all.

SWORD Health is an AI Care company that is making healthcare AI first. Within our suite of solutions, some qualify as medical devices (SFW and HW), and we are committed to ensuring the safety and efficacy of our devices, in order to attain the best outcomes possible.

We're seeking a highly motivated and experienced Senior Quality Engineer specializing in AI/ML to join our growing Quality and Regulatory Affairs team. This fully remote role (Portugal residents only) offers the opportunity to play a critical role in ensuring the safety and effectiveness of our cutting-edge AI-powered SaMD products. You'll be at the forefront of digital health, working with a dynamic team to bring innovative solutions to patients worldwide.

As a Senior Quality Engineer-AI, you will be a key player in ensuring the quality and regulatory compliance of our AI-driven Software as a Medical Device (SaMD) products. Reporting to the Sr. Manager of Quality Assurance, you will collaborate closely with cross-functional teams, including AI/ML engineers, product managers, and regulatory experts. This hands-on role requires a deep understanding of AI/ML software lifecycle processes, regulatory compliance, and risk management within the medical device industry.

• Quality Assurance for AI/ML- enabled SaMD: 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.). This includes guiding AI/ML development teams on quality processes, conducting reviews of engineering activities, and overseeing model retraining and updates.
• Regulatory compliance for AI/ML: Interpret and implement relevant regulatory guidance relevant regulations and guidance (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.
• Risk management: 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.
• Verification and Validation: 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.
• Documentation and Process Development: 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.
• Training and Communication: 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.
• Continuous Improvement: Lead continuous improvement initiatives to enhance AI/ML development and quality processes. Stay updated on emerging regulatory trends and technological advancements in AI/ML.

• 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.

• 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.

Portugal - Sword Benefits & Perks:

• 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

Note: Please note that this position does not offer relocation assistance. Candidates must possess a valid EU visa and be based in Portugal.

Sword Health, which includes SWORD Health, Inc. and Sword Health Professionals (consisting of Sword Health Care Providers, P.A., SWORD Health Care Providers of NJ, P.C., SWORD Health Care Physical Therapy Providers of CA, P.C.*) complies with applicable Federal and State civil rights laws and does not discriminate on the basis of Age, Ancestry, Color, Citizenship, Gender, Gender expression, Gender identity, Gender information, Marital status, Medical condition, National origin, Physical or mental disability, Pregnancy, Race, Religion, Caste, Sexual orientation, and Veteran status.