Manager, Validation & Verification (Medical Devices)

Location: Hybrid in Boston, Massachusetts, United States

Salary: $103,600–$176,400 annual base pay

Company

hirify.global develops medical device and software-enabled products for regulated healthcare applications.

What you will do

• Lead the Validation & Verification team for medical device, software, and system-level product development programs.
• Establish V&V strategies, schedules, resource plans, test protocols, methods, reports, and objective evidence.
• Provide technical and compliance oversight for design verification, validation, requirements traceability, defect investigations, and change impact assessments.
• Partner with Systems Engineering, Software, Hardware, Quality, Regulatory, Project Management, and Operations to resolve risks and execution barriers.
• Approve V&V documentation and support regulatory submissions, audit readiness, design history files, and product release decisions.
• Improve V&V processes, tools, metrics, automation practices, and test management approaches while developing team capability.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or a related technical discipline.
• At least 8 years of relevant experience in medical devices, software or system verification, validation, quality engineering, systems engineering, or regulated product development.
• Prior people leadership, project leadership, or technical team leadership experience.
• Experience leading cross-functional teams, managing priorities across multiple projects, presenting to leadership, and improving engineering processes.
• Knowledge of FDA Quality System Regulation, ISO 13485, IEC 62304, ISO 14971, design controls, risk management, requirements management, and V&V documentation.
• Experience with requirements and test management tools such as Polarion, DOORS, Jama, or similar platforms.

Nice to have

• Training or certification in medical device quality systems, software validation, risk management, Agile development and testing, project management, or engineering leadership.
• Experience with test management, defect management, engineering change control, process standardization, metrics, and operational excellence.

Culture & Benefits

• Diverse and dynamic work environment.
• 401(k) with up to a 6% employer match and no vesting period.
• Employee stock purchase plan and long-term incentive plan eligibility, depending on the role.
• Flexible time off for salaried employees, paid sick time, holidays, and parental leave.
• Disability insurance, tuition reimbursement, and health and welfare benefits.