Software Quality Assurance Engineer

• Embed with engineering teams to understand existing documentation practices and automation tools for software design, V&V activities, and change control, then produce standardized templates, work instructions, and SOPs that can be applied consistently across teams with similar cloud-native product lines.
• Serve as the primary author and owner of software lifecycle documentation artifacts including Software Development Plans (SDPs), Software Requirements Specifications (SRS), Software Design Documents (SDD), Verification & Validation Plans and Reports, and Software Risk Management Files
• Drive document change control processes from initiation through approval, coordinating review cycles to keep releases on schedule.
• Establish and maintain traceability matrices linking software requirements, design elements, risk controls, test cases, and defects, ensuring end-to-end objective evidence is audit-ready at any point in the release cycle.
• Own the documentation project plan for each software release, tracking open documentation tasks, review cycles, and approval gates as a parallel workstream to the engineering release schedule.
• Facilitate documentation readiness reviews prior to design freeze, test execution, and regulatory submission milestones. Communicate readiness status to engineering leads; escalate blockers early and drive resolution.

• Bachelor's degree in Computer Science, Software Engineering, or a closely related technical discipline required.
  • Advanced degree or professional certifications (ASQ CSQE, ISTQB, RAC) a plus but not required in lieu of demonstrated experience).
• 5–8 years of combined experience in software quality engineering, software development, or a closely adjacent technical role, with at least 2 years in an FDA-regulated environment (medical devices, digital health, or pharmaceutical software).
• Hands-on software development background — you must be able to read and reason about Go, Java or Python code, Infrastructure-as-Code (Terraform, Ansible), and automated test code (Playwright, pytest) without requiring a developer to walk you through it.
• Demonstrated experience producing IEC 62304-compliant documentation for Class B or Class C software
• Practical knowledge of ISO 14971 risk management methodology as applied to medical device software; experience authoring or materially contributing to FMEAs and software hazard analyses.
• Working knowledge of FDA cybersecurity expectations for medical devices, including familiarity with NIST frameworks and the ability to assess cloud-hosted systems against those standards.
• Familiarity with cloud-native architectures (microservice and event-driven architectures at scale, networking, IAM) sufficient to understand system design documents and workflows.
• Direct experience writing automated tests in Python or Go, or using Playwright for UI/E2E test automation

• You default to automation and repeatability over manual processes, and you can articulate why that matters for regulatory defensibility, not just engineering velocity.
• You are a skilled communicator who can translate between regulatory language and engineering language — equally comfortable in a design review with a Go developer and a regulatory affairs meeting.
• You take documentation quality as seriously as software quality: clarity, precision, version control, and traceability are not overhead to you, they are the work.
• You are comfortable working independently across multiple teams, managing your own priorities, and driving cross-functional coordination without formal authority.

About DEKA:

One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.