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. Delivering a 62% reduction in pain and a 60% reduction in surgery intent, at Sword, we are using technology to save millions for our 2,500+ 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, General Catalyst, and Khosla Ventures. Recognized as a Forbes Best Startup Employer in 2023, 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 $2 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 800+ (and growing!) talented colleagues, spanning two continents. Your charge? To help us build a pain-free world, powered by technology, enhanced by people — accessible to all. SWORD Health is a health care company that provides virtual and digital physical therapy. Sword is committed to providing high-quality medical devices (SFW and HW) that improve patient outcome and safety. As part of our ongoing commitment to excellence, we are seeking a talented and detail-oriented Medical Devices Software Quality Engineer. Reporting to the Sr. QARA Director, as Quality Systems Engineer (Software), you will play a crucial role in ensuring the quality and regulatory compliance of our software-based medical devices. You will collaborate with cross-functional teams, including software development, regulatory affairs, and quality assurance, to uphold the highest standards of safety and effectiveness. You will apply your core skills across a range of deployment platforms such as mobile applications, cloud services, edge devices and AI platforms. You will have an opportunity to work across a variety of therapeutic areas and operating room safety and efficiency.Key responsibilities:Software Quality Assurance:Develop and implement quality assurance processes and procedures specific to software development for medical device;Guide product development teams through our QMS and Software Engineering Lifecycle process to ensure software is developed in compliance with internal procedures as well as FDA and ISO and other regulatory bodies requirements;Conduct evaluation of software engineering activities of medical device new product development including requirements, software risk analysis, and design, development, documentation, integration, verification, validation and release activities to deliver medical devices that are safe, secure and effective;Provide quality engineering input to impact the design, coding, and debugging of software in various coding languages including SOUP software;Support software build, maintenance, defect management, and change control activities.Regulatory compliance:Stay updated and provide guidance on relevant industry standards, regulations, and guidelines (, ISO13485, FDA QSR, IEC 62304, IEC 82304, FDA 21 CFR , FDA CFR Part 11 Compliance, FDA General Principles of Software Validation, IEC 14971) to ensure compliance throughout the software development lifecycle.Risk management:Collaborate with cross-functional teams to identify, assess, and mitigate risks associated with software development for medical devices. Support the creation of software risk analyses and test strategies to ensure safe and reliable products are launched to SWORD's high quality standards.Verification and Validation:Plan, coordinate, and execute software verification and validation activities to ensure the accuracy and completeness of software requirements.Documentation and Reporting:Prepare and maintain accurate and comprehensive documentation related to software quality activities, including reports, test plans, and risk assessments.Collaboration and Communication:Work closely with software development teams to provide guidance on quality-related matters and facilitate effective communication between teams.Root Cause Analysis:Conduct root cause analysis for software-related quality issues and implement corrective and preventive actions (CAPAs) as necessary.Training and Support:Provide training and support to internal teams on quality-related processes and procedures related to software development.Skills and expertise:Bachelor's degree in Science, Engineering or related discipline.3+ years of experience in Quality Software Engineering or a related role within a regulated environment, preferably in medical devices or pharmaceuticals.Experience in medical device new product development preferred.Ideally, relevant work experience in Software quality management of medical devices including Software as Medical Device (SaMD).Strong knowledge of software development lifecycle processes and best practices ( Agile, Waterfall).Familiarity with relevant quality standards and regulations: Quality Management System ISO 13485, SiMD IEC 62304, SaMD IEC 82304, FDA 21 CFR , FDA CFR part 11 Compliance, knowledge and experience with FDA General Principles of Software Validation, IEC 14971 Risk Management, IEC 81001-5-1 Health Software and Health IT Systems Safety, Effectiveness and Security, UL 2900-1 Cybersecurity Standard for Medical Devices.Experience with risk management methodologies ( FMEA)Excellent analytical, problem-solving and communication skillsExperience with Agile, Jira, Confluence preferred.Fluent in English
