Senior Software (Quality Engineer 4) - CoE structure

Description

The company builds software for medical devices, including SaMD, SiMD, digital health, AI/ML-enabled products and cloud-connected healthcare solutions.

This is a technical quality role that joins work early, before verification, to spot technical risk and shape how software gets built.

You work alongside software engineering, systems engineering, product security, regulatory affairs and product quality teams as a technical partner and independent quality authority. Engineering keeps ownership of requirements, architecture, implementation and design specifications.

You bring strong software engineering knowledge and a current view of modern development practice, and you challenge technical decisions with objective, risk-based assessment.

Responsibilities

• Represent Product Quality for software-intensive products and provide independent quality oversight across the lifecycle.
• Work with software and systems engineers to build quality in from the start.
• Join architecture, design and technical reviews to find quality, reliability, maintainability and cybersecurity risks before code is written.
• Check engineering practices against recognised engineering and quality principles.
• Push for shift-left quality so defects are prevented rather than only caught by later verification.
• Check lifecycle work against IEC 62304, ISO 13485, FDA Quality System requirements and internal procedures.
• Review requirements, design specifications, risk controls, traceability, verification plans and release evidence for lifecycle integrity.
• Advise on Agile, DevOps, CI/CD, iterative and hybrid development methods.
• Judge engineering outputs for quality, completeness, maintainability, testability and technical risk.
• Act as an independent voice on quality and risk in architecture and design reviews.
• Assess designs for scalability, modularity, reliability, resilience, maintainability and testability.
• Review integrations, interfaces, cloud-connected systems, APIs, embedded systems and software platforms.
• Question assumptions and lead risk-based discussions on design and implementation choices.
• Assess source control, branching, build management, release management and product traceability.
• Check CI/CD pipelines and automated quality gates for effectiveness and compliance.
• Review release readiness criteria, build reproducibility, deployment steps and software integrity safeguards.
• Oversee the software bill of materials (SBOM), configuration baselines and release governance.
• Assess verification and validation strategies using risk-based, quality-focused methods.
• Evaluate automation frameworks, test coverage, traceability, defect trends and verification effectiveness.
• Encourage automated testing at unit, integration, system, API, performance and end-to-end levels.
• Bring testability into requirements and architecture discussions.
• Evaluate software cybersecurity risk across the lifecycle.
• Work with Product Security and Cybersecurity teams to advance Secure SDLC practice.
• Take part in threat modelling, security risk assessments, vulnerability reviews and cybersecurity readiness work.
• Support compliance with FDA cybersecurity guidance, NIST frameworks and secure medical device practice.
• Support quality and regulatory oversight of AI/ML-enabled software.
• Assess AI lifecycle controls for data quality, model validation, bias mitigation, transparency and traceability.
• Promote risk-based validation for AI-enabled healthcare products.
• Support adopting new technology without compromising patient safety, product quality or compliance.
• Help develop and improve software quality processes and procedures.
• Take part in CAPA investigations, root cause analysis, audits, inspections and improvement projects.
• Build and track software quality metrics that support risk-based decisions.
• Mentor engineering teams on software quality practice.

Requirements

• A Bachelor's or Master's degree in computer science, software engineering, electrical or biomedical engineering, or a closely related technical field.
• At least 8 years in software engineering, software quality, software test, systems engineering or related development work.
• Hands-on experience in software development, testing, automation, DevOps, systems engineering or product development.
• Proven ability to evaluate software implementations, not just review documents.
• Ability to assess lifecycle execution against IEC 62304, FDA Quality System requirements, ISO 13485 and internal procedures.
• Solid grasp of the full SDLC: requirements, architecture, design, implementation, verification, deployment, maintenance and post-market support.
• Working knowledge of programming concepts and software development practice.
• Ability to read and assess source code, architecture diagrams, interface designs and implementation approaches.
• Ability to review production software, architecture and technical design decisions.
• Ability to review source code, pull requests, automation frameworks and CI/CD workflows for quality, reliability, maintainability and compliance risk.
• Experience with languages such as C++, Python, C, Java, JavaScript or similar, enough to judge implementation quality and technical risk.
• Able to engage credibly with software engineers, understand architecture choices, review technical artifacts and influence quality independently across the lifecycle.
• Experience with Git-based source control.
• Understanding of modern software configuration management principles.
• Experience with CI/CD tools such as Azure DevOps, Jenkins, GitHub Actions, GitLab CI/CD or equivalent.
• Knowledge of build systems, deployment pipelines, release management and traceability controls.
• Experience evaluating or building automated test solutions.
• Knowledge of unit, integration, system and performance testing methods.

Conditions

The company and its customers may require current proof of vaccination against certain diseases, including COVID-19. Requirements vary by role.

Some roles may be subject to U.S. export controls that apply to prospective employees who are nationals of embargoed or sanctioned countries. Information you provide may be used to decide whether an export license or a Technology Control Plan (TCP) is needed. Licensing can take 3 to 6+ months, and a TCP typically adds 2 weeks.

For roles under export controls, any offer depends on an approved export license and/or an executed TCP before the start date. That timing may or may not be flexible but will not unreasonably delay hiring. Candidates will be told if this applies.

Qualified applicants with arrest and conviction records are considered in line with fair chance laws.

Preference is given to qualified candidates who do not live, and do not plan to live, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina or Tennessee.

The level may differ from the one listed, depending on business need and the selected candidate's experience, knowledge and skills.

Pay is based mainly on the level the role is filled at and the candidate's qualifications, as allowed by law.