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.
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.
EEO Policy Statement
Pay Transparency:
The base salary range for this role is:
$103,600.00-$176,400.00/Annual
Benefits
Health insurance401(k)Paid time offFlexible scheduleEquity / stock optionsPerformance bonusParental leave
Additional Information
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.
Haemonetics · Boston, MA