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Lead Software Quality Assurance Engineer
2 months ago
ABOUT TRUVIAN SCIENCES
Truvian Sciences is at the forefront of revolutionizing blood diagnostics, merging healthcare with cutting-edge technology. Our mission is to create an automated benchtop diagnostic system that delivers lab-quality results in under 30 minutes for a wide array of health assessments. We are currently pursuing FDA clearance for our innovative approach, which aims to make blood testing both affordable and accessible. Imagine a future where a single blood sample can yield critical health insights in minutes, whether in a retail environment or a private clinic.
JOB SUMMARY
As we embark on our next phase of growth, we are in search of a highly experienced Senior/Staff Software Test Engineer to play a pivotal role in our mission. This position is essential for executing software verification and validation tasks, establishing the testing framework, and implementing processes for medical software product testing. Responsibilities include authoring test cases, mentoring junior engineers, driving automation efforts, and engaging in all related verification and validation activities across various platforms including desktop, web, and mobile applications.
KEY RESPONSIBILITIES
- Conduct software verification and validation in accordance with established procedures, utilizing test cases and protocols for effective execution.
- Create and integrate comprehensive verification and validation test cases to ensure high software quality standards.
- Generate verification documentation, including reports and objective evidence, to substantiate testing results.
- Perform software and product testing on medical devices, including the handling of biological materials.
- Collaborate closely with software engineering and other departments to ensure timely delivery of high-quality software products.
- Support an agile development environment, focusing on value delivery and continuous improvement.
- Build strong relationships with the Quality and Regulatory teams to ensure compliance with all quality and regulatory standards.
- Provide oversight and guidance to development teams on software test engineering principles.
- Enhance and maintain test automation frameworks, including scripting and automation processes.
- Train and collaborate with internal and external personnel on software verification and validation methodologies.
- Apply risk management principles, such as hazard analysis and FMEAs, to inform software testing strategies.
- Participate in meetings to guide project management and represent software testing interests.
- Review and revise testing documentation to ensure quality and consistency.
- Work with cross-functional teams to identify and mitigate risks to patient safety.
- Engage in change management activities and participate in audits as required.
QUALIFICATIONS
Education: Bachelor's degree in Engineering (Electrical, Mechanical, Computer Science, etc.) or a related technical field.
Experience:
- Senior Software Test Engineer: Minimum of 8 years of relevant experience.
- Staff Software Test Engineer: Minimum of 12 years of relevant experience.
SKILLS & EXPERTISE
- Extensive background in software testing practices, particularly within the medical device sector.
- In-depth knowledge of FDA regulations and industry standards, including 21 CFR Part 11, GMP, ISO 13485, and IEC 62304.
- Proficiency in test automation frameworks, with ISTQB certification preferred.
- Understanding of cybersecurity principles and advanced computer skills, including statistical analysis and report writing.
- Strong organizational and analytical skills, with the ability to work effectively in both team settings and independently.
- Constructive assertiveness to foster continuous improvement and maintain positive communication with stakeholders.
SUPERVISORY ROLE
No supervisory responsibilities.
SALARY RANGE
- Senior Software Test Engineer: $118,000 - $140,000
- Staff Software Test Engineer: $147,000 - $158,000
PHYSICAL DEMANDS
- Ability to lift and move objects over 10 lbs. safely.
- Frequent standing and walking; specific vision abilities required include close vision, distance vision, and depth perception.
Truvian Sciences is an equal opportunity employer, committed to diversity and inclusion in the workplace.
