Software Quality Assurance Engineer
DEKA Research and Development Corporation2 months ago
Manchester, NH, USASenior
Responsibilities
- Embed with cloud-native engineering teams to assess documentation practices and automation tools and create standardized templates, work instructions, and SOPs.
- Own software lifecycle documentation such as Software Development Plans, Software Requirements Specifications, Software Design Documents, V&V plans and reports, and Software Risk Management Files.
- Drive document change control from initiation through approval and coordinate review cycles to keep releases on schedule.
- Maintain traceability matrices connecting requirements, design elements, risk controls, test cases, and defects.
- Own release documentation project plans, track documentation tasks and approval gates, and facilitate readiness reviews.
- Communicate documentation readiness, escalate blockers, and drive resolution across engineering and regulatory stakeholders.
Requirements
- Bachelor's degree in Computer Science, Software Engineering, or a closely related technical discipline.
- 5–8 years of combined experience in software quality engineering, software development, or a closely adjacent technical role.
- At least two years of experience in an FDA-regulated environment such as medical devices, digital health, or pharmaceutical software.
- Ability to read and reason about Go, Java or Python code, Terraform, Ansible, and automated test code.
- Experience producing IEC 62304-compliant documentation for Class B or Class C software.
- Practical knowledge of ISO 14971 risk management for medical-device software, including FMEAs and software hazard analyses.
- Working knowledge of FDA medical-device cybersecurity expectations and familiarity with NIST frameworks.
- Familiarity with cloud-native architectures, networking, IAM, microservice and event-driven architectures, and system workflows.
- Direct experience writing automated tests in Python or Go or using Playwright for UI/E2E test automation.
- Advanced degree or certifications such as ASQ CSQE, ISTQB, or RAC are preferred but not required.
- Strong communication, independent prioritization, cross-functional coordination, and automation-first process skills.
About DEKA Research and Development Corporation
DEKA Research & Development Corporation is a privately held R&D firm that invents and develops medical devices, robotics, and manufacturing systems for healthcare and technology partners. Founded in 1982 by Dean Kamen and headquartered in Manchester, NH, it typically licenses or transfers its designs to external manufacturers for mass production. Notable projects include the iBOT stair-climbing mobility system and the LUKE prosthetic arm supported by DARPA.