A fast-growing medical device company developing advanced respiratory diagnostic systems that combine hardware, algorithms, embedded software, and cloud analytics.

The QA & Validation Lead will establish software and system verification and validation processes, take ownership of product quality, and ensure compliance with top regulatory and clinical standards.

Key Responsibilities:

• Develop, design and execute detailed test plans and protocols for both black-box and white-box testing methodologies
• Perform testing: product validation and verification of software, algorithmic, hardware, and cloud components across integrated medical device systems
• Take ownership of product quality including test coverage and release readiness
• Support development activities such as bug life-cycle management and identification of requirement / design gaps
• Develop and maintain test scripts and automation to enhance testing processes
• Write, review, and maintain documentation to support regulatory compliance
• Support interactions with and submissions to local and global regulatory and certification bodies as needed
  
  

Requirements:

• Bachelor’s or higher Degree/s in Biomedical Engineering, Computer science, Mechanical Engineering or a related field
• Proven experience in writing and executing test-plans for SW solutions
• Experience in writing / maintaining testing automations
• Team player with an excellent interpersonal and communication skills with a proactive, hands-on approach
• Basic programming (MATLAB, Python, other) skills - advantage
• Experience working with medical or similar regulated products – advantage
• Fluent English – both written and spoken – required