Principal Software Test Lead

Haemonetics Software Solutions; Boston (MA); On-site; USD 103,600 - 176,400; Full time

Benefits offered by this job

401(k) with up to a 6% employer match

Employee stock purchase plan

Flexible time off

Tuition reimbursement

Health and welfare benefits

Job summary

Haemonetics Software Solutions is looking for a Senior Technical Leader in Boston to define and execute Verification & Validation (V&V) strategies for Software as a Medical Device (SaMD) and SaaS platforms. The role involves ensuring compliance with FDA standards and providing technical leadership for software quality.

With 10+ years of experience, the candidate will drive quality metrics, manage test automation, and promote a culture of continuous improvement in a dynamic Agile environment. Competitive salary and comprehensive benefits are offered.

Qualifications

• 10+ years of experience executing V&V strategy for Software as a Medical Device (SaMD) and SaaS platforms.
• Hands-on experience with traceability matrices.
• Proven leadership in mentoring and guiding engineering teams.

Responsibilities

• Lead and define software V&V strategy for both non-medical and medical device software.
• Drive compliance with FDA design controls and quality management systems.
• Develop and implement robust test plans and test cases tailored to product needs.

Skills

Test automation

Quality metrics

Agile methodologies

Analytical skills

Problem-solving

Communication skills

Education

Bachelor’s or Master’s degree in Engineering, Computer Science, or related field

Tools

Compliance frameworks

Job description

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.

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.

Responsibilities

• Lead and define software V&V strategy for both non‑medical and medical device software.
• Drive compliance with FDA design controls, IEC62304, ISO14971, 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.

Qualifications

• 10+ years of experience executing 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.

Pay Transparency

The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job‑knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics’ employee compensation. For non‑sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company’s long‑term incentive plan, with eligibility and target amount dependent on the role. The base salary range for this role is: $103,600.00–$176,400.00 per annum.

Benefits

• 401(k) with up to a 6% employer match
• Employee stock purchase plan
• Flexible time off for salaried employees; accrual of three to five weeks of vacation annually (based on tenure) for hourly employees
• Accrual of up to 64 hours of paid sick time annually
• Paid and/or floating holidays
• Parental leave
• Short‑ and long‑term disability insurance
• Tuition reimbursement
• Health and welfare benefits

EEO Policy Statement

Equal Employment Opportunity is a core value at Haemonetics. We are committed to a workplace that reflects fairness and respect for all employees and aspiring applicants. All decisions regarding employment are based on merit and qualifications without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, or any other characteristic protected by law.