Validation & Verification Leader, Medical Devices

Regulatory Jobs; Boston (MA); Hybrid; USD 104,000 - 176,000; Full time

Job summary

Haemonetics seeks a Manager of Validation & Verification to lead V&V activities for medical device and software products. You will provide technical direction, oversight, and coaching to a cross-functional team in Boston.

You will establish strategies, schedules, and test evidence aligned with design controls and regulatory standards, while collaborating with Systems, Software, Hardware, Quality, and Regulatory partners.

Qualifications

• Bachelor's degree in engineering, computer science, biomedical engineering, or related technical discipline required.
• Minimum of 8 years of relevant experience in medical device/software/system verification, validation, quality engineering, or related regulated product development.
• Prior people leadership, project leadership, or technical team leadership experience required.
• Experience with FDA Quality System Regulation, ISO 13485, IEC 62304, ISO 14971, design controls, risk management, and requirements management preferred.
• Experience with requirements and test management tools such as Polarion, DOORS, Jama or similar platforms preferred.

Responsibilities

• Develop team capability through coaching, performance management, workload balancing, hiring support, training, and professional development planning.
• Lead and manage the Validation & Verification team responsible for planning, developing, executing, and documenting verification and validation activities for medical device and software-enabled products.
• Establish and maintain V&V strategies, schedules, resource plans, and deliverables aligned with product development milestones, regulatory expectations, and business priorities.
• Provide technical and compliance oversight for test plans, requirements traceability, protocols, test methods, test reports, defect investigations, and objective evidence supporting design verification and validation.
• Drive consistent application of design controls, risk management, test method validation, software validation, and quality system procedures across assigned programs.
• Partner with cross-functional leaders to identify verification and validation risks, remove execution barriers, support issue resolution, and communicate impacts to project scope, schedule, quality, and compliance.
• Review and approve verification and validation documentation, including test protocols, reports, traceability matrices, deviations, nonconformances, and change impact assessments.
• Promote continuous improvement in V&V processes, tools, templates, metrics, automation practices, and test management approaches to improve quality, efficiency, and predictability.
• Prepare and present clear status updates, technical summaries, resource needs, risks, and recommendations to functional leadership and program stakeholders.
• Ensure team deliverables support regulatory submissions, audit readiness, design history files,and product release decisions as applicable.

Skills

People leadership

Cross-functional collaboration

Project leadership

Regulatory knowledge

Communication

Education

Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or related technical discipline

Tools

Polarion

DOORS

Jama

Job description

Haemonetics seeks a Manager of Validation & Verification to lead V&V activities for medical device and software products. You will provide technical direction, oversight, and coaching to a cross-functional team in Boston.

You will establish strategies, schedules, and test evidence aligned with design controls and regulatory standards, while collaborating with Systems, Software, Hardware, Quality, and Regulatory partners.