What are the responsibilities and job description for the Senior/Staff Software Quality Engineer position at Truvian?
ABOUT
Are you ready to be part of a groundbreaking company reshaping the future of blood testing? Truvian is a healthcare pioneer, merging diagnostics and consumer tech to develop an automated benchtop diagnostic system. This system is designed to deliver lab-accurate results in just 30 minutes for a comprehensive suite of health tests. Our unique approach, currently seeking FDA clearance, aims to make accessible and affordable blood testing a reality, all from a single small blood sample in minutes, whether in a retail setting or a private clinic.
At Truvian, our work is not just a job—it’s a mission. We are a culture of discovery and empowerment, dedicated to putting health information where it belongs—in the hands of the individual. We are united in the belief that a talented team can turn every day into an adventure. Join us as we work towards our vision of making routine health testing convenient, affordable, and actionable for today’s connected consumers and empowering them with the health information they need.
JOB SUMMARY
As we enter our next evolution phase, Truvian seeks a Senior/Staff Software Quality Engineer. The primary function of this role is not just to define the testing framework and implement processes but to contribute significantly to our mission of making routine health testing convenient, affordable, and actionable. Your role in authoring test cases, training junior engineers, driving test automation, and participating in V&V activities is crucial to our success. The candidate must participate in a team-oriented environment to develop requirements and test artifacts for desktop, web, and mobile applications.
He or she must provide technical V&V leadership and guidance for junior software test engineers, including, but not limited to, documentation writing, specifications coverage, and verification planning and execution. The ideal candidate will have extensive IVD V&V experience.
This role will report directly to the Sr. Manager, Software Engineering.
HERE’S WHY YOU’LL LOVE THIS JOB:
The ideal candidate will have a minimum of a BS degree in Engineering (Electrical, Mechanical, Computer science, etc.) or equivalent Technical Field experience. The candidate will bring 5 or more years of experience in IVD/Medical Devices software testing. The ideal candidate will have extensive design controls, risk management experience, and exposure to the life sciences, diagnostics, and/or medical devices industries.
In addition to educational requirements, candidate will have:
• No
SALARY RANGE
Senior SW Quality Engineer Range $120,000 – $135,000
Staff SW Quality Engineer Range $140,000 - $160,000
ONSITE @ Truvian
This range considers the wide range of factors that are considered in making compensation decisions, including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. Salary offers are determined based on the final candidate's qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications.
PHYSICAL DEMANDS AND ABILITIES
Truvian provides equal employment opportunities to all employees and applicants for employment 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 company reshaping the future of blood testing? Truvian is a healthcare pioneer, merging diagnostics and consumer tech to develop an automated benchtop diagnostic system. This system is designed to deliver lab-accurate results in just 30 minutes for a comprehensive suite of health tests. Our unique approach, currently seeking FDA clearance, aims to make accessible and affordable blood testing a reality, all from a single small blood sample in minutes, whether in a retail setting or a private clinic.
At Truvian, our work is not just a job—it’s a mission. We are a culture of discovery and empowerment, dedicated to putting health information where it belongs—in the hands of the individual. We are united in the belief that a talented team can turn every day into an adventure. Join us as we work towards our vision of making routine health testing convenient, affordable, and actionable for today’s connected consumers and empowering them with the health information they need.
JOB SUMMARY
As we enter our next evolution phase, Truvian seeks a Senior/Staff Software Quality Engineer. The primary function of this role is not just to define the testing framework and implement processes but to contribute significantly to our mission of making routine health testing convenient, affordable, and actionable. Your role in authoring test cases, training junior engineers, driving test automation, and participating in V&V activities is crucial to our success. The candidate must participate in a team-oriented environment to develop requirements and test artifacts for desktop, web, and mobile applications.
He or she must provide technical V&V leadership and guidance for junior software test engineers, including, but not limited to, documentation writing, specifications coverage, and verification planning and execution. The ideal candidate will have extensive IVD V&V experience.
This role will report directly to the Sr. Manager, Software Engineering.
HERE’S WHY YOU’LL LOVE THIS JOB:
- You'll work with a rock-star team of people who are passionate about the work they do and our ability to disrupt healthcare with our innovative products
- You’ll be a key player on a team responsible for the company’s growth and product launch
- You thrive in a fast-paced and dynamic environment where you can implement fresh ideas and new processes and make things happen quickly without a bunch of red tape
- You’ll have great perks such as Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), paid parental leave, flexible PTO, Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks, on-site gym and virtual classes, and a farm to table onsite restaurant including a 30% discount
- Contribute to design control outputs, including SRS and quality Assurance deliverables (test cases, plans, protocols, reports), to ensure full and accurate coverage for verification/validation, release, and FDA submission.
- Ensure SQA team compliance with applicable policies, procedures, and regulations through regular reviews and feedback.
- Provide quality oversight and guidance to project teams by ensuring that Software Quality Engineering principles are utilized to develop and enhance robust, safe, and effective products.
- Build working relationships with the Quality/Regulatory team to drive effective compliance with quality and regulatory requirements and needs.
- Develop and provide training to company personnel and external resources for the software development and verification/validation program.
- Create, review, and execute software-related deliverables per the Software Development Life Cycle, such as Requirements, Development/V&V Plans, Risk and Hazard Analysis, Test Plans/Protocols/Reports, Design Specifications, Configuration Management, etc.
- Provide quality oversight and guidance around risk management deliverables (hazard analysis, FMEAs, etc.)
- Ensure software-related deliverables are integrated with higher-level system and component quality deliverables.
- Follow and enhance software event/defect tracking procedures.
- Interface with external partners in V&V activities.
- Identify areas for improving regulatory compliance and continuous improvement opportunities for products and processes.
- Represent software quality assurance at project meetings and guide project and functional management.
- Review, revise, and write instructions and procedures. Ensure quality and consistency in documentation and adherence to internal procedures, applicable standards, and regulatory requirements.
- Work with cross-functional teams to collectively identify, analyze, estimate, and reduce risks to patient safety.
- Create and/or review and approve change activities.
- Participate in internal and external audits and respond to audit observations as needed.
- Perform other duties as assigned.
The ideal candidate will have a minimum of a BS degree in Engineering (Electrical, Mechanical, Computer science, etc.) or equivalent Technical Field experience. The candidate will bring 5 or more years of experience in IVD/Medical Devices software testing. The ideal candidate will have extensive design controls, risk management experience, and exposure to the life sciences, diagnostics, and/or medical devices industries.
In addition to educational requirements, candidate will have:
- Detailed knowledge of FDA and industry/international standards (including 21 CFR Part 11), GMP, IEEE 1012 and ISO 13485, IEC 62304, IEC 60601, IEC 61010, HIPAA
- Knowledgeable of FDA 21 CFR Part 820.30, Quality System Regulations (QSR), Medical Device Directive, ISO 13485 and 14971 standards, FDA Pre-Market & Post-Market Cybersecurity Guidance, and international cybersecurity regulations/guidance such as IMDRF, ANSI/UL 2900.
- Experience in software testing practices, methodologies, and techniques, particularly in testing medical devices. IVD is a plus.
- Experience in Test Automation frameworks and processes.
- Understanding and application of basic cybersecurity principles.
- ASQ CSQE certification desired.
- Advanced computer skills, including statistical/data analysis and report writing skills.
- Organizational, planning, and detail follow-up skills required.
- Strong analytical skills and effective problem-solving ability.
- Ability to work in a multi-functional team environment.
- Demonstrated ability to be flexible and resourceful.
- Ability to work independently, with minimal supervision.
- Utilize a constructively assertive approach that reaches out, speaks up, and drives continuous improvement.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• No
SALARY RANGE
Senior SW Quality Engineer Range $120,000 – $135,000
Staff SW Quality Engineer Range $140,000 - $160,000
ONSITE @ Truvian
This range considers the wide range of factors that are considered in making compensation decisions, including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. Salary offers are determined based on the final candidate's qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications.
PHYSICAL DEMANDS AND ABILITIES
- Regularly required to use hands to finger, handle, or feel, reach with hands and arms, and talk or hear
- Ability to lift and move over 25 lbs. repeatedly and safely, occasionally 75 lbs. with assistance
- Frequently required to stand, walk, stoop, kneel, crouch or crawl
- Occasionally required to sit and climb or balance
- 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 for employment 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.
Salary : $120,000 - $160,000