Software Quality Assurance Engineer for Medical Devices
3 semanas atrás
Sword Health is a pioneering healthcare company on a mission to revolutionize the way pain is managed. With a global presence and a growing team of talented professionals, we're committed to delivering innovative solutions that improve patient outcomes.
Salary: $120,000 - $150,000 per yearThis is a highly competitive salary range based on industry standards and the specific requirements of this role.
About the RoleWe're seeking an experienced Software Quality Assurance Engineer to join our team. As a key member of our software development team, you'll be responsible for ensuring the quality and regulatory compliance of our software-based medical devices.
Your primary focus will be on developing and implementing quality assurance processes and procedures specific to software development for medical devices. You'll work closely with cross-functional teams, including software development, regulatory affairs, and quality assurance, to uphold the highest standards of safety and effectiveness.
You'll have the opportunity to apply your expertise across a range of deployment platforms, including mobile applications, cloud services, edge devices, and AI platforms. Your work will have a direct impact on improving patient outcomes and enhancing the overall quality of our medical devices.
Key Responsibilities- Develop and implement quality assurance processes and procedures specific to software development for medical devices.
- 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.
- 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.
- Ideal candidate should have 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 (e.g Agile, Waterfall).
- Familiarity with relevant quality standards and regulations: Quality Management System ISO 13485, SiMD IEC 62304, SaMD IEC 82304, FDA 21 CFR 820.30, 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 (e.g. FMEA).
- Excellent analytical, problem-solving and communication skills.
- Experience with Agile, Jira, Confluence preferred.
- Fluent in English.
As a valued member of our team, you'll enjoy a comprehensive benefits package, including:
- Comprehensive health, dental and vision insurance.
- Equity shares.
- Discretionary PTO plan.
- Parental leave.
- 401(k).
- Flexible working hours.
- Remote-first company.
- Paid company holidays.
Please note that this position does not offer relocation assistance. Candidates must possess a valid EU visa and be based in Portugal.
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