Lead, Validation & Verification – Medical Devices

haemonetics; Boston (MA); On-site; USD 104,000 - 176,000; Full time

Benefits offered by this job

401(k) with up to 6% match

Employee stock purchase plan

Flexible time off

Paid vacation

Paid holidays

Parental leave

Job summary

Haemonetics is seeking a Manager of Validation & Verification to lead verification and validation activities across medical device and software-enabled products. You will oversee a capable team, ensure test strategies and documentation meet design controls and quality standards, and collaborate across Systems Engineering, Software, Hardware, Quality, Regulatory, and Operations.

You will drive continuous improvement in V&V processes, manage risks, and communicate status and resource needs to

Qualifications

• Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or related technical discipline.
• Minimum of 8 years in medical device/software/system verification & validation or related regulated development.
• Experience in people leadership, project leadership, or technical team leadership.
• Familiarity with FDA Quality System Regulation, ISO 13485, IEC 62304, ISO 14971, design controls, risk management.
• Experience with requirements and test management tools such as Polarion, DOORS, Jama.
• Experience leading cross-functional teams and improving engineering processes.

Responsibilities

• Develop team capability through coaching and performance management.
• Lead V&V team to plan, develop, execute, and document verification activities.
• Establish V&V strategies, schedules, and deliverables aligned with milestones.
• Provide technical and compliance oversight for test plans and reports.
• Drive design controls, risk management, and software validation across programs.
• Partner with cross-functional leaders to manage risks and resources.
• Review and approve verification documentation and reports.
• Promote continuous improvement of V&V processes and tools.
• Prepare status updates and communicate risks to leadership.
• Ensure deliverables support regulatory submissions and audit readiness.
• Other duties as assigned.

Skills

People leadership

Project leadership

Technical leadership

Regulatory knowledge

FDA QSR familiarity

Requirements management

Test method validation

Cross-functional collaboration

Leadership communication

Jama/Polarion/DOORS

Education

Engineering or related technical discipline

Tools

Polarion

DOORS

Jama

Job description

Haemonetics is seeking a Manager of Validation & Verification to lead verification and validation activities across medical device and software-enabled products. You will oversee a capable team, ensure test strategies and documentation meet design controls and quality standards, and collaborate across Systems Engineering, Software, Hardware, Quality, Regulatory, and Operations.

You will drive continuous improvement in V&V processes, manage risks, and communicate status and resource needs to