Senior Software Quality Assurance Engineer II
Our Company
Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES
• Develop, write, and execute formal software verification and validation protocols according to product requirements and user needs.
• Create verification/validation test plans based on a scope of development work.
• Coordinate between Software QA and other departments to ensure the products meet requirements and user needs.
• Work closely with the R&D teams to aid data gathering and reproduction, documentation, and triaging of issues.
• Development of functional testing protocols (e.g., unit test, integration tests, white-box, and black box testing).
• Ensure verification completeness and compliance with general standards and Gentuity’s quality management system.
• Other duties as assigned.
EXPERIENCE/SKILL REQUIREMENTS
Required:
• 8+ years of experience with software testing and verification in a medical device product environment.
• A quick-learning, initiative-taking individual who is confident working with different teams.
• Ability to multi-task and operate within a fast-paced environment.
• Excellent oral, written, analytical, technical, and interpersonal skills.
• A solid grasp on good documentation practices.
• Experience testing risk control measures.
• Experience working in an iterative development methodology (e.g. Agile/Scrum).
The following are considered a plus:
• Understanding of Quality System requirements and regulations relative to medical device software.
• Cybersecurity experience. Penetration testing, working on cybersecurity in a regulated environment.
• Experience with testing of embedded software in medical, scientific, and analytical devices.
• Experience writing automated testing scripts (JavaScript or similar scripting language).
• Software testing experience working in a continuous integration software environment.
EDUCATIONAL REQUIREMENTS
Bachelor’s degree in a technical field (Computer sciences, EE, Physics, Biomedical, etc.) or prior experience with software verification