Software Quality Engineer, Senior Level, Contractor

Siro Diagnostics, Inc. is seeking an experienced Senior Software Quality Engineer contractor to support a specific software quality Development and Design validation project for the Company’s in-vitro diagnostic medical device platform.This is a project-based independent contractor role. The contractor will support software design controls, software validation, software quality documentation, and maintenance of validated state for software used in Siro’s medical device products and manufacturing processes.This is not a software testing engineer role. The focus is software quality engineering ensuring compliance to IEC 62304, for Software Development and software validation, design control compliance, risk documentation, and regulated software lifecycle support.Contract Details:Role type: Independent contractorProject: Software quality, software validation, and design control support for in-vitro diagnostic medical device softwareExpected time commitment: Approximately 40 hours per weekHourly rate: $60-$70 per hour, depending on experienceLocation: San Diego on site (Hybrid considered within Southern California)Duration: Project-based, to be defined based on project needsResponsibilities may include:Review and approve validation protocols and validation reports for software used in Siro’s medical device products and manufacturing processesCreate and maintain functional requirements and risk assessments for medical device software and software used in manufacturingSupport the maintenance of software systems in a validated stateSupport software development teams in creating software design history file documentation, including software development plans, software verification and validation plans, product requirements documents, software requirements specifications, software architecture and design specifications, software risk management files, test protocols and reports, and traceability matricesEnsure software quality documentation conforms to internal SOPs, applicable external standards, and industry best practicesSupport compliance with FDA 21 CFR 820, IEC 62304, ISO 14971, IEC 62304 IEC 62366, ISO 13485, and applicable FDA guidance for medical device software validationSupport software quality improvement through software quality assurance metrics, analytical tools, and documentation practicesWork cross-functionally with software development, quality, regulatory, manufacturing, and product teamsPerform other project-related duties as assignedRequirements:Bachelor’s degree in Computer Science, Computer Engineering, Software Engineering, or equivalent experience5+ years of experience in software quality assurance, software development, system administration, computer system validation, or related software quality work in a regulated industryExperience supporting software validation and software lifecycle documentation in a medical device, diagnostics, life sciences, or other regulated environmentUnderstanding of software quality principles and practices in a regulated industryWorking knowledge of software development tools, including code repositories, version control, compilers, build tools, IDEs, continuous integration, and static or dynamic code analysis toolsKnowledge of FDA guidance for medical device software validationUnderstanding of ISO 13485 principlesKnowledge of AAMI TIR36 preferredStrong Microsoft Office skills, including Word, Excel, and PowerPoint, for documentation, trending, reporting, and metricsStrong written and verbal communication skillsAbility to work independently in a fast-paced startup environment with shifting priorities and competing demandsEnvironment and Physical Requirements:This role is expected to be performed primarily in a remote indoor work environment. No adverse working conditions are expected. The role may require:Remaining in a stationary position for extended periodsRepeating motions such as typing or using a computerCommunicating with others to exchange informationOccasionally moving, lifting, carrying, pushing, or pulling objects up to 20 poundsAbout Siro Diagnostics:Siro Diagnostics is developing point-of-care molecular diagnostic technology. Our team is focused on building a high-quality platform that supports fast, reliable, and accessible diagnostic testing.