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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 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

• Bachelors or Masters 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 pay actually offered to the successful candidate will take into account without limitation the candidates 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 Companys 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- Monday through Friday 7:30 a.m. 5 p.m. ET or email .

The base salary range for this role is: