Manager, Validation & Verification

Haemonetics

. Lead and manage the Validation & Verification team for medical device and software-enabled products .

Posted 10/2/2026full-timeBoston • Massachusetts • United StatesSeniorLead💰 $103,600 - $176,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading Validation & Verification teams for medical devices and software-enabled products, with a strong focus on compliance oversight, risk management, and process improvement. Proven ability to manage cross-functional collaboration and deliver regulatory submissions effectively.

Highest-signal resume keywords

Validation & Verification LeadershipFDA Quality System RegulationISO 13485Requirements Management ToolsRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation & VerificationQuality EngineeringSystems EngineeringTest Method ValidationDesign ControlsRequirements TraceabilityDefect InvestigationTest PlanningProcess ImprovementProject Management

Soft Skills

CoachingPerformance ManagementCommunicationTeam LeadershipIssue Resolution

Tools & Technologies

PolarionDOORSJamaTest Management Tools

Certifications & Qualifications

Medical Device Quality Systems CertificationSoftware Validation CertificationRisk Management CertificationAgile Development CertificationProject Management Certification

Industry Keywords

Medical DeviceSoftware ValidationRegulated Product DevelopmentIEC 62304ISO 14971

About the role

Key responsibilities & impact

Lead and manage the Validation & Verification team for medical device and software-enabled products
Develop team capability through coaching, performance management, workload balancing, hiring support, training, and professional development planning
Establish and maintain V&V strategies, schedules, resource plans, and deliverables
Provide technical and compliance oversight for test plans, requirements traceability, protocols, test methods, test reports, defect investigations, and objective evidence
Drive application of design controls, risk management, test method validation, software validation, and quality system procedures
Partner with Systems Engineering, Software, Hardware, Quality, Regulatory, Project Management, and Operations
Identify V&V risks, remove execution barriers, support issue resolution, and communicate project impacts
Review and approve verification and validation documentation, deviations, nonconformances, and change impact assessments
Improve V&V processes, tools, templates, metrics, automation practices, and test management approaches
Present status updates, technical summaries, resource needs, risks, and recommendations to leadership and stakeholders
Ensure deliverables support regulatory submissions, audit readiness, design history files, and product release decisions
Supervise individual contributors, technical leads, contractors, and external test resources
Perform other duties as assigned

Requirements

What you’ll need

Bachelor of Arts or Science 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, 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
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 preferred
Experience with requirements and test management tools such as Polarion, DOORS, Jama, or similar platforms 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

Benefits

Comp & perks

Discretionary annual bonus for non-sales roles
Eligibility for the Company’s long-term incentive plan
401(k) with up to a 6% employer match and no vesting period
Employee stock purchase plan
Flexible time off for salaried employees
Three to five weeks’ vacation annually for hourly employees, based on tenure
Up to 64 hours annually of paid sick time
Paid and/or floating holidays
Parental leave
Short- and long-term disability insurance
Tuition reimbursement
Health and welfare benefits