Principal Software Test Lead

Haemonetics • Boston, MA

1d

About The Position

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.

Requirements

• 10 years experience executing Verification & Validation (V&V) strategy for Software as a Medical Device (SaMD) and SaaS platforms
• Bachelor’s or Master’s degree in Engineering, Computer Science, or related field.
• Strong expertise in test automation, quality metrics, and Agile methodologies.
• Hands-on experience with traceability matrices and compliance frameworks.
• Experience with SaaS/cloud-based systems
• Proven leadership in mentoring and guiding engineering teams.
• Strong analytical, problem-solving, and communication skills.

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 assessments, and drive defect resolution.
• Support audits, submissions, and inspections with complete, accurate, and traceable documentation.
• Drive continuous improvement in testing processes, efficiency, and integration within Agile workflows.

Benefits

• 401(k) with up to a 6% employer match and no vesting period
• employee stock purchase plan
• flexible time off for salaried employees
• accrual of three to five weeks’ vacation annually (based on tenure) for hourly employees
• accrual of up to 64 hours (annually) of paid sick time
• paid and/or floating holidays
• parental leave
• short- and long-term disability insurance
• tuition reimbursement
• health and welfare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Principal