Quality & Validation Engineer

About Us

At Prenuvo, we are on a mission to flip the paradigm from reactive “sick-care” to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). Our unique integrated stack of optimized hardware, software, and increasingly AI, coupled with the patient-centric experience across our domestic and global clinics, have allowed us to lead the change against “we caught it too late again".

As a Quality & Validation Engineer, you will play a crucial role in mitigating product risks and accelerating quality and regulatory processes through rigorous testing and documentation. You will develop and execute verification and validation plans and protocols, ensure compliance with medical device regulations, and work cross-functionally to maintain the highest standards of product quality, reliability, safety and effectiveness.

This is a hybrid position open to candidates based in Vancouver, Toronto or the Bay Area.

Help reshape the world through proactive healthcare while working with cutting-edge technology and high performing teams with deep expertise - join us to make a difference in people’s lives!

What You’ll Do

• Develop and implement V&V strategies for AI-based medical imaging products to meet FDA and other regulatory standards .
• Design, execute, and document test plans, protocols and reports (IQ, OQ, PQ) to QA software components and systems.
• Collaborate with AI researchers, software engineers, and regulatory teams to ensure seamless integration of quality and compliance processes.
• Conduct risk assessments, failure mode analyses, and root cause investigations to enhance product reliability.
• Maintain documentation in compliance with ISO 13485, 14971, IEC 62304, 62366 and other relevant medical device regulations.
• Establish and monitor quality control processes, including software verification and validation activities.
• Support regulatory submissions by providing test documentations , risk analyses, and other compliance documentation.
• Participate in internal and external audits, ensuring adherence to quality management system (QMS) requirements.
• Drive continuous improvement initiatives to enhance testing efficiency and regulatory compliance.

What You’ll Bring

• Bachelor’s or Master’s degree in Biomedical Engineering, Electrical Engineering, Computer Science, or a related field.
• Hands-on knowledge of Python programming language, test frameworks, and git
• Hands-on experience with test automation tools and CI/CD like Jenkins, Github Actions
• 3+ years of experience in quality assurance, validation, or regulatory compliance within the medical device or healthcare industry.
• Experience with software verification and validation for AI/ML-based medical applications.
• Hands-on experience with statistical analysis tools and validation methodologies.
• Excellent problem-solving skills and attention to detail.
• Strong technical writing skills for regulatory documentation.
• Ability to work effectively in a cross-functional team environment.

Nice to Have

• Knowledge of FDA regulations, including 21 CFR Part 820, 21 CFR Part 11, and ISO 13485.
• Experience with machine learning model performance testing  and algorithmic bias assessment.
• Knowledge of Good Automated Manufacturing Practice (GAMP 5) and computer system validation (CSV).
• Previous experience with software development lifecycle (SDLC) in a regulated environment.
• Familiarity with risk management principles (ISO 14971) and medical imaging standards (DICOM, PACS).
• Familiarity with cybersecurity considerations for medical AI applications.

Our Values

First: we are Pioneers

• Transforming healthcare requires divergent thinking, bias for action, disciplined experimentation, and consistent grit and determination to maintain momentum. This journey is as challenging as it is rewarding.

Second: we are Platform-Builders

• We’re always building foundations that allow us to achieve tomorrow more than we did today. We never lose sight of what’s ahead – in a mindset of ownership and duty to our mission.

Above all: we are Patients

• We could all be the next person who walks through our very doors, seeking clarity or peace of mind. We are proud of our impact on our patients’ lives, and we won’t stop till everyone can benefit from our work.

What We Offer

• An avenue to make a positive impact on people's lives and their health
• We believe in preventative healthcare for everyone, including our team - Prenuvo provides free, whole-body scans to each team member 
• Growth opportunities are at the heart of our people journey, we’re doing big things with bright minds - there is no single path to success, it can be shaped along the way
• Building strong relationships is at the core of everything we do - our team gets together each week to connect, share, and socialize 
• Recognizing time away to restore is vital to our wellbeing - we have a flexible vacation policy and we will encourage you to use it
• We offer a comprehensive benefits package including health, dental, vision, including Mental Health coverage, to support you and your family
• The base salary for this role ranges from $140,000 - $160,000 in local currency, depending upon experience

We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

As part of the hiring process, successful candidates will undergo a background check in compliance to applicable federal, provincial, and state rules.

Please be advised that official communication from our recruitment team will only come from our authorized domain [prenuvo.com]. If you are contacted by a recruiter, please ensure their email address ends with @prenuvo.com. We do not use third-party recruitment services or any other email domains for hiring purposes. If you receive communication that you believe to be fraudulent, please report it immediately to jobs@prenuvo.com.