R&D System Verification & Validation Test Manager (MedTech)

Location: Irvine, California, United States

Annual salary: $131,000–$180,000, plus eligibility for an annual bonus.

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions, including defibrillators, patient monitors, ventilators, and trauma products.

What you will do

• Lead, direct, and oversee system-level design verification and validation programs for new and modified medical products.
• Plan, budget, schedule, and track Design Quality Assurance activities across multiple concurrent development projects.
• Develop and execute hardware and software testing procedures incorporating simulated use, clinical performance, safety standards, risk management, and usability principles.
• Establish policies, procedures, test strategies, and standardized validation setups for stress and simulated-use testing.
• Review, audit, and approve quality assurance procedures, test results, and product-release documentation.
• Work with project managers, engineering managers, development teams, and Quality Assurance to resolve product design issues and improve design quality.

Requirements

• Bachelor’s degree in Software Engineering, Computer Science, or a similar field.
• 10+ years of experience in hardware and software Design Quality Assurance.
• 5+ years of hands-on software quality assurance experience with real-time embedded software systems.
• 5+ years of experience in a software Design Quality Assurance leadership role.
• Strong knowledge of software QA principles, practices, metrics, development, and testing best practices.
• Strong written, verbal, interpersonal, and business communication skills.

Nice to have

• Advanced degree.
• Familiarity with FDA and international standards and regulations for medical device hardware and software development, verification, and validation.
• Understanding of clinical environments and the clinical application of medical electronic products.
• Experience with modern software development and quality assurance tools.

Culture & Benefits

• Work in a fast-growing medical technology company operating in more than 140 countries.
• Contribute to products intended to improve outcomes for patients with critical cardiopulmonary conditions.
• Culture emphasizing innovation, self-motivation, and an entrepreneurial spirit.
• Comprehensive benefits and eligibility for an annual bonus.