Senior Manager, Medical Device Validation & Verification

Haemonetics Interventional Technologies; 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 and parental leave

Disability insurance

Tuition reimbursement

Health and welfare benefits

Job summary

Haemonetics Interventional Technologies seeks a Manager of Validation & Verification to lead V&V for medical device and software-enabled products. You will recruit, mentor, and guide a high-performing team while shaping test strategies and ensuring compliance with design controls and quality systems.

The role partners with Systems Engineering, Software, Hardware, Quality, Regulatory, and Operations to plan verification activities, manage risks, and improve testing processes across programs.

Qualifications

• Minimum 8 years in medical device, software, or system verification/validation and related regulated development.
• Prior people leadership, project leadership, or technical team leadership experience.
• Experience with FDA QSR, ISO 13485, IEC 62304, ISO 14971, design controls, risk management.
• Experience with requirements and test management tools like Polarion, DOORS, Jama.
• Experience leading cross-functional teams and improving engineering processes.

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 reports, defect investigations, and evidence supporting design verification and validation.
• Drive consistent application of design controls, risk management, test method validation, software validation, and quality system procedures across programs.

Skills

People leadership

Cross-functional collaboration

Test planning & execution

Regulatory awareness

Education

Bachelor's degree in Engineering/CS/Biomedical Engineering

Tools

Polarion

DOORS

Jama

Job description

Haemonetics Interventional Technologies seeks a Manager of Validation & Verification to lead V&V for medical device and software-enabled products. You will recruit, mentor, and guide a high-performing team while shaping test strategies and ensuring compliance with design controls and quality systems.

The role partners with Systems Engineering, Software, Hardware, Quality, Regulatory, and Operations to plan verification activities, manage risks, and improve testing processes across programs.