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Boston, Massachusetts, United States
Onsite
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.
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 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 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.
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 sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. 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.
In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks’ vacation annually (based on tenure), 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, and/or health and welfare benefits.
Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. – 5 p.m. ET or email AskHR@Haemonetics.com.
The base salary range for this role is: