Senior V&V Leader — Medical Devices & Software

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

Benefits offered by this job

401(k) with employer match

Employee stock purchase plan

Flexible time off

Paid sick time

Holidays

Parental leave

Disability insurance

Tuition reimbursement

Health and welfare benefits

Job summary

Haemonetics Corp in Boston seeks a Manager of Validation & Verification to lead the V&V team for medical device and software-enabled products. You will plan, execute, and document verification and validation activities ensuring compliance with design controls and quality systems.

The role requires coaching and developing the team, coordinating across Systems Engineering, Software, Hardware, Quality, Regulatory, and Operations, and delivering status updates to leadership.

Qualifications

• Bachelor's degree in engineering, CS, biomedical engineering or related technical discipline.
• 8+ years of relevant experience in medical device software, system verification/validation and quality engineering.
• Experience leading cross-functional teams and managing priorities across multiple projects.

Responsibilities

• Lead and manage the Validation & Verification team for medical device and software-enabled products.
• Develop and maintain V&V strategies, schedules, and resource plans aligned with milestones and regulatory expectations.
• Provide technical and compliance oversight for test plans, traceability, protocols, and test reports.
• Drive design controls, risk management, and quality system procedures across programs.
• Review and approve verification and validation documentation and change impact assessments.
• Promote continuous improvement of V&V processes, tools and metrics.

Skills

People leadership

V&V strategy

Cross-functional collaboration

Regulatory compliance

Test management

Education

Engineering degree

Tools

Polarion

DOORS

Jama

Job description

Haemonetics Corp in Boston seeks a Manager of Validation & Verification to lead the V&V team for medical device and software-enabled products. You will plan, execute, and document verification and validation activities ensuring compliance with design controls and quality systems.

The role requires coaching and developing the team, coordinating across Systems Engineering, Software, Hardware, Quality, Regulatory, and Operations, and delivering status updates to leadership.