Software Quality Assurance Engineer - medical device

InnoTech Staffing•Manchester, NH

5d•Onsite

About The Position

InnoTECH Staffing is seeking an automation-minded Software Quality Assurance Engineer to join an innovative cloud engineering team onsite in Manchester, New Hampshire. This individual-contributor role partners with development teams to integrate software quality, automation, documentation, and regulatory compliance into cloud-native engineering workflows. The engineer will help create repeatable, scalable processes and documentation frameworks that support product teams and enable developers to focus on innovation while maintaining software quality and regulatory compliance. The role includes embedding with cloud engineering teams to understand their technologies and practices, standardizing effective workflows, and owning software lifecycle documentation. The engineer will establish end-to-end traceability, coordinate document change control and release readiness, and lead documentation readiness reviews before design freezes, testing, and regulatory submission milestones. The position influences teams through technical expertise and collaboration rather than people management. It is fully onsite in Manchester, NH; remote and hybrid arrangements are not available.

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 related technical role.
Hands-on software development background and ability to read, understand, and evaluate Go, Java, or Python code; Infrastructure-as-Code such as Terraform or Ansible; and automated test code such as Playwright or pytest.
Demonstrated experience developing IEC 62304-compliant documentation for Class B or Class C software.
Practical knowledge of ISO 14971 risk management for medical device software, including experience authoring or substantially contributing to FMEAs and software hazard analyses.
Working knowledge of FDA cybersecurity expectations for medical devices, including familiarity with NIST frameworks and evaluating cloud-hosted systems against relevant security expectations.
Familiarity with cloud-native architectures, including microservices, event-driven systems, networking, and identity and access management (IAM).
Direct experience writing automated tests using Python or Go, or developing UI and end-to-end test automation with Playwright.
Ability to work independently across multiple teams, manage competing priorities, and drive projects forward without formal authority.
Ability to collaborate with developers, quality professionals, and regulatory stakeholders and translate between engineering practices and regulatory expectations.

Nice To Haves

Advanced degree.
Professional certifications such as ASQ CSQE, ISTQB, or RAC.
At least 2 years of experience in an FDA-regulated environment, such as medical devices, digital health, or pharmaceutical software.

Responsibilities

Embed with cloud-native engineering teams to understand development workflows, documentation practices, and automation tools.
Standardize effective engineering practices into templates, work instructions, and SOPs for adoption across similar product teams.
Create and maintain Software Development Plans (SDPs), Software Requirements Specifications (SRS), Software Design Documents (SDDs), Verification & Validation Plans and Reports, and Software Risk Management Files.
Integrate documentation, verification, and regulatory compliance into the software development lifecycle using automation-first, DevSecOps-oriented practices.
Coordinate document change control from initiation through review and approval, aligning documentation activities with engineering priorities and release schedules.
Establish and maintain traceability matrices connecting requirements, software design elements, risk controls, test cases, and defects.
Ensure objective evidence is complete, accurate, and audit-ready.
Own the documentation project plan for each software release, tracking deliverables, review cycles, open items, and approval milestones alongside the engineering release schedule.
Lead documentation readiness reviews ahead of design freezes, test execution, and regulatory submission milestones.
Identify documentation gaps early, communicate risks, and work with engineering leads to resolve issues before they affect delivery.
Help developers understand regulatory expectations and help quality and regulatory stakeholders understand modern cloud engineering practices.