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.

• Project:
  Software quality, software validation, and design control support for in-vitro diagnostic medical device software
• Expected time commitment:
  Approximately 40 hours per week
• Hourly rate: $60-$70 per hour, depending on experience
• Location:
  
  San Diego on site (Hybrid considered within Southern California)
• Duration:
  Project-based, to be defined based on project needs

Responsibilities may include:

• Review and approve validation protocols and validation reports for software used in Siro’s medical device products and manufacturing processes
• Create and maintain functional requirements and risk assessments for medical device software and software used in manufacturing
• Support the maintenance of software systems in a validated state
• Support 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 matrices
• Ensure software quality documentation conforms to internal SOPs, applicable external standards, and industry best practices
• Support compliance with FDA 21 CFR 820, IEC 62304, ISO 14971, IEC 62304 IEC 62366, ISO 13485, and applicable FDA guidance for medical device software validation
• Support software quality improvement through software quality assurance metrics, analytical tools, and documentation practices
• Work cross-functionally with software development, quality, regulatory, manufacturing, and product teams
• Perform other project-related duties as assigned

Requirements:

• Bachelor’s degree in Computer Science, Computer Engineering, Software Engineering, or equivalent experience
• 5+ years of experience in software quality assurance, software development, system administration, computer system validation, or related software quality work in a regulated industry
• Experience supporting software validation and software lifecycle documentation in a medical device, diagnostics, life sciences, or other regulated environment
• Understanding of software quality principles and practices in a regulated industry
• Working knowledge of software development tools, including code repositories, version control, compilers, build tools, IDEs, continuous integration, and static or dynamic code analysis tools
• Knowledge of FDA guidance for medical device software validation
• Understanding of ISO 13485 principles
• Knowledge of AAMI TIR
  36 preferred
• Strong Microsoft Office skills, including Word, Excel, and PowerPoint, for documentation, trending, reporting, and metrics
• Strong written and verbal communication skills
• Ability to work independently in a fast-paced startup environment with shifting priorities and competing demands

Environment 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 periods
• Repeating motions such as typing or using a computer
• Communicating with others to exchange information
• Occasionally moving, lifting, carrying, pushing, or pulling objects up to 20 pounds