Manager, Validation & Verification (Hybrid, Boston)

Haemonetics•Boston, MA

4d•Hybrid

About The Position

The Manager, Validation & Verification is responsible for leading validation and verification activities for medical device, software, and system-level product development programs. This role provides people leadership, technical direction, and execution oversight to ensure test strategies, protocols, methods, and objective evidence meet product requirements, design control expectations, quality system procedures, and applicable regulatory standards. The manager partners cross-functionally with Systems Engineering, Software, Hardware, Quality, Regulatory, Project Management, and Operations to plan and execute verification and validation work, resolve technical and compliance risks, improve test processes, and develop a high-performing team.

Requirements

Bachelors of Arts or Science 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, systems engineering, or related regulated product development; or equivalent relevant experience.
Prior people leadership, project leadership, or technical team leadership experience required.
Experience leading cross-functional teams, managing priorities across multiple projects, presenting to leadership, and improving engineering processes is required.

Nice To Haves

Experience working within FDA Quality System Regulation, ISO 13485, IEC 62304, ISO 14971, design controls, risk management, requirements management, test method validation, and verification and validation documentation is preferred.
Experience with requirements and test management tools such as Polarion, DOORS, Jama, or similar platforms is preferred.
Preferred: Training or certification in medical device quality systems, software validation, risk management, Agile development and test, project management, or related engineering leadership disciplines.

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.
Supervises individual contributors and technical leads, contractors, or external test resources. Responsibilities include hiring support, onboarding, goal setting, coaching, performance feedback, development planning, workload prioritization, and ensuring team compliance with applicable procedures and quality expectations.