Senior Software QA Engineer (Medical Devices)

TL;DR

Senior Software QA Engineer (Medical Devices): Designing and executing quality assurance and software validation for next-generation clinical and biopharma osmometers with an accent on regulatory compliance, risk management, and test traceability. Focus on validating hardware-integrated software, improving iterative test processes, and ensuring cybersecurity and reliability under FDA and ISO 13485 requirements.

Location: Hybrid schedule in Norwood, Massachusetts, with 4 days per week on-site

Salary: $120,000–$130,000 per year

Company

hirify.global develops clinical and biopharmaceutical instruments, including osmolality testing and in vitro diagnostic solutions, for customers in more than 100 countries.

What you will do

• Lead software QA processes, test strategies, procedures, and execution for assigned medical device projects.
• Develop test coverage, traceability documentation, validation plans, protocols, and reports.
• Perform manual and automated feature, regression, integration, and requirements-based testing.
• Assess software risks, define mitigation strategies, and monitor quality metrics.
• Collaborate with Engineering, Regulatory Affairs, and Quality Assurance to meet compliance requirements.
• Improve tools and workflows so verification activities run concurrently with iterative development.

Requirements

• Commercial software testing experience in medical devices, scientific instruments, or hardware-integrated systems.
• Experience testing and shipping medical devices under ISO 13485 and working with FDA requirements.
• Knowledge of software cybersecurity guidance, 21 CFR Part 11, and regulatory-compliant development.
• Experience with Azure DevOps or similar tools for backlogs, sprint boards, and test case management.
• Ability to configure PC, server, cloud-hosted, and hardware test environments.
• Understanding of Agile and waterfall lifecycles, third-party communication protocols, and APIs; relevant bachelor's degree or equivalent experience.

Culture & Benefits

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) company match, bonus program, generous paid time off, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Hybrid and flexible work arrangements with employee engagement events.
• Company marketplace and cafeteria support at selected Massachusetts and Maine offices.
• Physical requirements include extended computer work, effective remote communication, occasional office movement, and lifting up to 25–50 pounds as required.