US Tech Solutions
SaMD/Medical Devices Software Quality Engineer
US Tech Solutions, San Bruno, California, United States, 94066
Job Description:The client is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. The purpose is to bring the promise of precision health to everyone, every day.The client is focused on generating and activating data from a variety of sources, including clinical, social, behavioural and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence. Client’s unique expertise and capabilities in technology, data science and healthcare enable the entire healthcare ecosystem to drive better health outcomes.
Responsibilities:Quality Assurance Champion:
Act as a champion of Quality Assurance throughout the software development lifecycle, ensuring adherence to high standards and corporate requirements.Regulatory Compliance:
Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices from the medical device industry.Documentation and Support:
Support the creation and maintenance of Design History Files (DHF) including development plans, verification and validation plans, requirements specifications, and risk management files.Risk Management and Usability Engineering:
Integrate ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes.Training and Compliance:
Provide ongoing training and education on quality systems and SDLC frameworks, and support CAPA, complaints, audits, and overall QMS functions.
Mandatory:Medical Device Software Experience:
Proven experience in software development for medical devices, specifically focusing on Software as a Medical Device (SaMD) or low-risk enforcement discretion products. At least 3-5 years of recent experience in standalone software development, with a solid understanding of medical device software standards such as IEC 62304.Software Quality Engineering Expertise:
Hands-on experience in Software Quality Engineering (QE) rather than hardware or test engineering. Proficiency in applying quality principles throughout the software development lifecycle, including familiarity with SDLC processes and Quality Management Systems (QMS) compliant with US FDA regulations and ISO 13485.Tool Proficiency:
Demonstrated ability to effectively use a variety of tools required for product development and communication, including Google Suite. Experience with diverse tools for quality assurance and engineering tasks, showing adaptability to different environments.Agile and Microservices Experience:
Experience working in an agile development environment, particularly with microservice-based architectures.Exclusions:
No background in hardware engineering or test engineering roles (e.g., CSV background or test engineering experience). The focus is strictly on software quality engineering in a software-only context.
Skills:QMSSaMDAgile, Scrum or WaterfallMicroservices is preferredRisk ManagementDHF
Education:BA/BS degree or equivalent practical experience.
About US Tech Solutions:US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit
www.ustechsolutions.com .US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Responsibilities:Quality Assurance Champion:
Act as a champion of Quality Assurance throughout the software development lifecycle, ensuring adherence to high standards and corporate requirements.Regulatory Compliance:
Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices from the medical device industry.Documentation and Support:
Support the creation and maintenance of Design History Files (DHF) including development plans, verification and validation plans, requirements specifications, and risk management files.Risk Management and Usability Engineering:
Integrate ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes.Training and Compliance:
Provide ongoing training and education on quality systems and SDLC frameworks, and support CAPA, complaints, audits, and overall QMS functions.
Mandatory:Medical Device Software Experience:
Proven experience in software development for medical devices, specifically focusing on Software as a Medical Device (SaMD) or low-risk enforcement discretion products. At least 3-5 years of recent experience in standalone software development, with a solid understanding of medical device software standards such as IEC 62304.Software Quality Engineering Expertise:
Hands-on experience in Software Quality Engineering (QE) rather than hardware or test engineering. Proficiency in applying quality principles throughout the software development lifecycle, including familiarity with SDLC processes and Quality Management Systems (QMS) compliant with US FDA regulations and ISO 13485.Tool Proficiency:
Demonstrated ability to effectively use a variety of tools required for product development and communication, including Google Suite. Experience with diverse tools for quality assurance and engineering tasks, showing adaptability to different environments.Agile and Microservices Experience:
Experience working in an agile development environment, particularly with microservice-based architectures.Exclusions:
No background in hardware engineering or test engineering roles (e.g., CSV background or test engineering experience). The focus is strictly on software quality engineering in a software-only context.
Skills:QMSSaMDAgile, Scrum or WaterfallMicroservices is preferredRisk ManagementDHF
Education:BA/BS degree or equivalent practical experience.
About US Tech Solutions:US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit
www.ustechsolutions.com .US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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