- Identify key concerns regarding safety and effectiveness of our SaMD products.
- Collaborate with the verification and validations team to design studies that addresses these concerns of safety and effectiveness.
- Document these study design and their rationale in pre-submission/submission packages to US regulatory body.
- Assessable verification and validation documents in regulatory submission packages for US and other global regulatory agencies; work with the FDA as well as our global Samsung team to achieve device clearances.
- Participate in QMS process reviews and development of project timelines.
- PhD Degree in a relevant Science or Engineering field, such as Biomedical Engineering, Electrical Engineering, and Computer Science, or equivalent combination of education, training, and experience.
- 5+ years of relevant experience in medical device research or product development, preferably with experience in algorithm development, verification and validation, and/or regulatory affairs.
- Experience designing and/or conducting large scale clinical studies, with a working understanding of statistical methods used in those studies.
- Have strong experience in at least one, and is capable of transitioning between medical devices of different physiological domains ex. cardiovascular, endocrine, and/or neurological.
- Experience with medical device or wearable sensor technology.
- Relevant experience working within a medical deviceQuality Management System (21 CFR 820), with working understanding of proper design control, document management, risk management, and software development lifecycle processes.
- Experience in strategizing, assembling, and defending submission packages for medical devices with regulatory bodies is preferred.
- Ability to use a data analysis tool or programming language such as MATLAB, R, or Python is preferred.
Staff Engineer, Clinical Systems - Mountain View, United States - Samsung Research America
Description
Lab Summary:
Our mission is to empower Samsung's users to more easily monitor and manage their own and their loved one's health through advanced health service and medical device innovation. We specialize in developing Samsung's upcoming software-based medical devices and health services, including product definition and strategy, partner integrations, UI/UX design, usability research, clinical validation, regulatory submissions, and software development/lifecycle. Millions of Samsung users' lives around the world have been touched by our products, including the Samsung HeartWise cardiac rehabilitation App and the Samsung ECG Monitor App. Join us
Position Summary:
Samsung strives to offer superior digital health products on our wearables and phones, backed by world-class research, technical, and manufacturing capabilities. As a cross-disciplinary health-focused product development team consisting of research, technology, design, strategy and product functions, we define the next generation of mobile health product and service experiences for Samsung devices.
As a Clinical Systems Engineer, you will be guiding software-as-a-medical-device (SaMD) projects on appropriate clinical study strategy that contributes toward successful regulatory submissions and clearances. This includes the ability to understand scientific principals of various physiological signals and algorithms that utilizes them.
You will be responsible for designing the appropriate bench, on-human, and/or clinical studies to verify and validate SaMD algorithms, including formulating comprehensive rationale for study population, methodology, and endpoints. You will work also closely with our clinical operations team in delivering quality study reports. You will assemble these reports and summarize them as appropriate in our regulatory submissions and defend them during interactions with said regulatory bodies.
Position Responsibilities:
Experience Requirement: