PrincipalSoftwareTestLead

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. ## Job Details Senior technical leader responsible for defining and executing Verification & Validation (V&V) strategy for Software as a Medical Device (SaMD) and SaaS platforms. Drives regulatory compliance, quality metrics, traceability, and scalable test automation in a regulated Agile environment. Provides technical leadership for software quality, ensuring alignment with FDA expectations and Haemonetics quality standards. # __**Key Responsibilities:**__ * Lead and define software V&V strategy for both non-med and medical device software. * Drive compliance with FDA design controls, IEC 62304, ISO 14971, and quality management systems. * Provide technical leadership, mentorship, and review of V&V deliverables to ensure rigor, quality, and consistency across programs * Develop and implement robust test plans, and test cases tailored to product and project needs * Oversee test design, execution, and V&V across API, UI, backend, and integrated systems. * Develop and implement automated testing strategies, promote a culture of automation. * Establish, track, and report software quality metrics to drive data-informed decisions. * Diagnose, document, and troubleshoot systems to resolve problems identified through testing and see them through to a successful resolution * Recommend adjustments to resolve software issues and improve the functionality of existing software. * Create and maintain traceability matrices linking requirements, risks, and verification and validation activities. * Provide technical leadership and mentorship to engineers on V&V, compliance, and best practices. * Collaborate cross-functionally with Development/Architecture teams, QA, Product Owners, and Business stakeholders to ensure comprehensive test coverage, conduct risk asse