Senior Quality Engineer

Smith+Nephew•Pittsburgh, PA

4d•Hybrid

About The Position

Smith+Nephew is seeking a Senior Design Quality Assurance Engineer to partner with cross-functional development teams and ensure the quality, safety, and regulatory compliance of medical devices and software applications throughout the product lifecycle. The position provides quality leadership, risk management expertise, and guidance on software validation, verification, and regulatory compliance for new product development and design change projects.

Requirements

Master's degree in Engineering, Computer Science, or a related discipline and 4+ years of experience in quality assurance, software testing, automation, or software development; or a bachelor's degree in one of these fields and 6+ years of relevant experience; or an associate degree and 8+ years of relevant experience.
Strong understanding of Design Quality Assurance principles, including design requirements and specifications, risk assessments and risk management, requirements traceability, unit, integration, and regression testing, automated testing methodologies, and design and code reviews.
Experience applying ISO 13485, ISO 14971, and IEC 62304.
Experience working within regulated industries, preferably medical devices.
Knowledge of FDA Quality System requirements, including 21 CFR Part 820 and Quality Management System Regulations.
Experience supporting software verification and validation activities.
Ability to work effectively with geographically dispersed and cross-functional teams.
Strong analytical, problem-solving, and communication skills.
Ability to work independently with minimal supervision.

Nice To Haves

Software Quality Engineer Certification.
Experience with Agile development methodologies, including SAFe.
Experience developing and executing manual and automated test suites.
Experience with BDD/TDD methodologies.
Experience with Linux environments.
Experience with Angular, React CLI, Jest, SpecFlow, Cucumber, Jasmine, JUnit, or NUnit.
Experience testing mobile applications on iOS and Android platforms.
Experience working with multiple programming languages and software development environments.

Responsibilities

Lead Design Quality Assurance activities for new product development and design change projects.
Complete and facilitate product risk assessments, including FMEAs and other risk management activities.
Review and approve design input requirements, specifications, and traceability documentation.
Review and approve software unit tests and support integration, verification, and validation testing activities.
Complete Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for Quality System tools.
Support audits, CAPAs, non-conformances, and compliance investigations as required.
Mentor engineering teams on software development lifecycle best practices, risk management, and design control compliance.