SaMD/Medical Devices Software Quality Engineer
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About The Position
The SaMD/Medical Devices Software Quality Engineer position at US Tech Solutions is pivotal in ensuring the quality and compliance of software products within the medical device sector. The role emphasizes a data-driven approach to healthcare, aiming to enhance how individuals manage their health and how healthcare is delivered. The engineer will be responsible for championing quality assurance throughout the software development lifecycle, ensuring that all processes adhere to high standards and corporate requirements. This includes ensuring compliance with US FDA Quality System Regulations and ISO 13485, integrating best practices from the medical device industry into the development processes. In this role, the engineer will support the creation and maintenance of Design History Files (DHF), which encompass development plans, verification and validation plans, requirements specifications, and risk management files. A significant aspect of the position involves integrating risk management and usability engineering activities with software development lifecycle (SDLC) processes, particularly focusing on ISO 14971 and IEC 62366 standards. The engineer will also provide ongoing training and education on quality systems and SDLC frameworks, supporting Corrective and Preventive Actions (CAPA), complaints, audits, and overall Quality Management System (QMS) functions. The ideal candidate will have proven experience in software development for medical devices, particularly in Software as a Medical Device (SaMD) or low-risk enforcement discretion products. A solid understanding of medical device software standards, particularly IEC 62304, is essential. The role requires hands-on experience in Software Quality Engineering, with proficiency in applying quality principles throughout the SDLC. Familiarity with various tools for product development and communication, including Google Suite, is necessary, along with experience in agile development environments, especially with microservice-based architectures.
