Senior/Staff Software Test Engineer
San Diego - Onsite, CA
Full Time
Experienced
ABOUT
Are you ready to be part of a groundbreaking team that is reshaping the future of blood testing? Truvian, a dynamic healthcare company at the crossroads of diagnostics and consumer tech, aims to develop an automated benchtop diagnostic system. This system will deliver lab-accurate results in under 30 minutes for a comprehensive range of health tests. Our unique approach, currently undergoing FDA clearance, aims to make affordable and accessible blood testing a reality. We envision a future where a single blood sample can provide health insights within minutes in a retail setting or private clinic.
At Truvian, our work is more than just a job – it is a mission. We are a culture committed to discovery and empowerment. As pioneers in our field, we are dedicated to putting health information where it belongs - in the hands of the individual. We believe that every day can be an adventure with the right team. Join us as we work towards making routine health testing convenient, affordable, and actionable for today’s connected consumers!
JOB SUMMARY
As Truvian advances into its next phase of evolution, we seek a highly skilled Senior/Staff Software Test Engineer (onsite) to join our dynamic team. In this role, you will be crucial to our mission, performing software verification and validation activities, defining the testing framework, and implementing medical software product testing processes. You will also author test cases, mentor junior test engineers, drive test automation, and actively participate in all related verification and validation activities across desktop, web, and mobile applications.
The successful candidate will provide technical leadership and guidance in software V&V, covering documentation writing, specifications coverage, verification planning and execution, and requirements grooming. Extensive experience in IVD V&V is highly preferred. This role reports directly to Software Engineering Management, ensuring alignment with team goals and objectives.
HERE’S WHY YOU’LL LOVE THIS JOB:
Education: Bachelor’s degree in an Engineering field (Electrical, Mechanical, Computer Science, etc.) or an equivalent technical field.
Experience:
Skills & Expertise:
SUPERVISORY ROLE
SALARY RANGE
PHYSICAL DEMANDS AND ABILITIES
Truvian provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Are you ready to be part of a groundbreaking team that is reshaping the future of blood testing? Truvian, a dynamic healthcare company at the crossroads of diagnostics and consumer tech, aims to develop an automated benchtop diagnostic system. This system will deliver lab-accurate results in under 30 minutes for a comprehensive range of health tests. Our unique approach, currently undergoing FDA clearance, aims to make affordable and accessible blood testing a reality. We envision a future where a single blood sample can provide health insights within minutes in a retail setting or private clinic.
At Truvian, our work is more than just a job – it is a mission. We are a culture committed to discovery and empowerment. As pioneers in our field, we are dedicated to putting health information where it belongs - in the hands of the individual. We believe that every day can be an adventure with the right team. Join us as we work towards making routine health testing convenient, affordable, and actionable for today’s connected consumers!
JOB SUMMARY
As Truvian advances into its next phase of evolution, we seek a highly skilled Senior/Staff Software Test Engineer (onsite) to join our dynamic team. In this role, you will be crucial to our mission, performing software verification and validation activities, defining the testing framework, and implementing medical software product testing processes. You will also author test cases, mentor junior test engineers, drive test automation, and actively participate in all related verification and validation activities across desktop, web, and mobile applications.
The successful candidate will provide technical leadership and guidance in software V&V, covering documentation writing, specifications coverage, verification planning and execution, and requirements grooming. Extensive experience in IVD V&V is highly preferred. This role reports directly to Software Engineering Management, ensuring alignment with team goals and objectives.
HERE’S WHY YOU’LL LOVE THIS JOB:
- Work with a passionate, high-performing team dedicated to disrupting healthcare with innovative products.
- Play a vital role in the company’s growth and product launch, contributing to impactful projects.
- Thrive in a fast-paced, dynamic environment where fresh ideas and new processes are welcomed and quickly implemented.
- Enjoy excellent perks, including generous benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), paid parental leave, flexible vacation time, and access to on-site amenities like an on-site gym, virtual classes, craft coffee, Kombucha, cold brew, healthy snacks, and a farm-to-table restaurant with a 30% discount.
- Perform software verification and validation activities according to operating procedures, leveraging test cases/protocols to execute verification and creating ad hoc test protocols for continuous integration testing.
- Author and integrate verification and validation test cases, ensuring comprehensive software quality coverage.
- Produce verification artifacts, such as reports and objective verification evidence, to document testing outcomes.
- Conduct software/product testing on medical devices, including handling biological materials such as blood and control material.
- Collaborate closely with software engineering and other teams to ensure high-quality software/product deliverables, providing timely feedback on design/feature implementation.
- Support an agile development and testing environment, focusing on value delivery and continuous improvement.
- Build and maintain strong working relationships with the Quality/Regulatory team to ensure compliance with quality and regulatory requirements.
- Provide test oversight and guidance to development teams, ensuring that software test engineering principles are applied to develop robust, safe, and effective products.
- Establish and enhance test automation frameworks, including automation and scripting.
- Train and interface with company personnel and external resources on software verification/validation processes.
- Apply a solid understanding of risk management deliverables, such as hazard analysis and FMEAs, to inform software testing.
- Participate in meetings, guide project and functional management, and represent software testing interests.
- Review, revise, and write instructions and procedures to ensure quality and consistency in testing documentation.
- Work with cross-functional teams to identify, analyze, estimate, and reduce risks to patient safety.
- Create, review, and approve change activities. Participate in internal and external audits, responding to audit observations as needed.
- Perform other duties as assigned.
Education: Bachelor’s degree in an Engineering field (Electrical, Mechanical, Computer Science, etc.) or an equivalent technical field.
Experience:
- Senior Software Test Engineer: At least 8 years of experience.
- Staff Software Test Engineer: At least 12 years of experience.
Skills & Expertise:
- Extensive experience in software testing practices, particularly in medical devices and software. IVD experience is highly preferred.
- Detailed knowledge of FDA and industry/international standards, including 21 CFR Part 11, GMP, IEEE 1012, ISO 13485, IEC 62304, IEC 60601, IEC 61010, and HIPAA.
- Proficiency in test automation frameworks and processes, with ISTQB certification highly desired.
- Understanding and application of basic cybersecurity principles, with advanced computer skills, including statistical/data analysis and report writing.
- ASQ CSQE certification is a plus.
- Strong organizational, planning, and follow-up skills and excellent analytical and problem-solving abilities.
- Ability to work effectively in a multi-functional team environment and independently with minimal supervision.
- Constructive assertiveness to drive continuous improvement and maintain positive, cooperative communications with all stakeholders.
SUPERVISORY ROLE
- No
SALARY RANGE
- Senior Software Test Engineer: $118,000 - $140,000
- Staff Software Test Engineer: $147,000 – $158,000
PHYSICAL DEMANDS AND ABILITIES
- Ability to lift and move over 10 lbs. repeatedly and safely
- Frequently required to stand, walk; specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus
Truvian provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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