Quality & Validation Engineer, Prenuvo
CA$140-160k
Whole body MRI scans
Be an early applicant
Whole body MRI scans
201-500 employees
Be an early applicant
CA$140-160k
201-500 employees
Company mission
Prenuvo's mission is to transform the medical paradigm from reactive to proactive, ridding the world of advanced disease by detecting it early when treatment is easiest and most successful.
Role
Who you are
- 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
Desirable
- 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
What the job involves
- 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
- 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
Our take
The quantified self movement is gaining momentum, especially in the health and fitness sector. Wearable health monitors, sleep trackers, and genetic testing have all firmly entered the mainstream, and body MRI scanning service Prenuvo is taking this concept to the next level. Prenuvo’s whole body diagnostic imaging offers customers a comprehensive picture of their body, whilst screening for 500+ major conditions and cancers.
The medical benefits of approaching these diseases proactively, as opposed to reactively, are substantial. Customers will be able to catch warning signs early, meaning treatment is likely to be less invasive, with a higher success rate. Unfortunately North America, like many regions, has yet to make substantial investments in preventative healthcare. This just makes companies like Prenuvo, and the VCs who fund them, increasingly necessary.
This funding, however has been substantial, and having closed a Series A funding round in 2022 Prenuvo has moved swiftly to open new clinics across the United States. Its next step is to improve the accessibility of its service - currently scans cost about $1000, but improvements in the technology and working processes will cut the cost by two thirds or more and greatly expand Prenuvo's addressable market.
Steph
Company Specialist at Welcome to the Jungle
Insights
Company
Funding (2 rounds)
Dec 2024
$120m
SERIES B
Oct 2022
$56m
SERIES A
Total funding: $176m
Company benefits
- Save Lives: Early detection is key to healthier lives. We do the incredibly rewarding work of giving people the information they need, as early as possible
- Social Events: Building strong relationships is at the core of everything we do. Our team gets together each week to connect, share, and socialize
- Full Body Scans: We believe in preventative healthcare for everyone, including our team. Prenuvo provides free, whole-body scans to each team member
- Coffee & Snacks: Daily health at Prenuvo means having space to take a break and refuel. We keep our break room stocked with coffee and healthy snacks
- We offer a comprehensive benefits package including health, dental, vision, including Mental Health coverage, and an Employee and Family Assistance Program to support you and your family
- Recognizing time away to restore is vital to our wellbeing - we have a flexible vacation policy and we will encourage you to use it
- 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
Leadership
Andrew Lacy
(CEO)Previously founded semantic search company Zaptravel (now Lebara Travel) and iPhone app company Tapulous (subsequently sold to Disney). Later joined Disney as the SVP of Disney Mobile, and then Lebara as Chief Product Officer. Alongside work at Prenuvo they also co-founded Azarus.
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