LAB SUMMARY:

Our mission is to empower people to live healthier lives by leveraging our wearables, smartphones, medical devices, AI, and health services. We research, develop, and commercialize innovative digital health products and solutions by bringing together the full capabilities of our team, including product strategy and management, clinical expertise, partnerships, UI/UX design, usability research, clinical research and validation, software development, AI / Gen AI, and regulatory submissions. Millions of Samsung users’ lives around the world have been touched by our products, including the Samsung HeartWise for cardiac rehabilitation and the Samsung ECG Monitor App. Samsung’s unique advantage in the consumer electronics market and growing focus on Digital Health and AI / Gen AI provides exciting technical challenges and rewarding career experience. Join us!

POSITION SUMMARY:

Samsung strives to offer superior consumer health products through 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 consumer health products and service experiences for Samsung devices.
As a Staff Systems Engineer, you will be primarily responsible for guiding medical device projects on appropriate development and regulatory strategy that contributes toward successful regulatory clearances and product launch. By collaborating with a cross-functional team, including manufacturing, on the appropriate requirements to ensure products are designed, developed, manufactured, and tested in compliance with global medical device regulations
With your ability to understand principles of various physiological signals and algorithms that utilizes them, you will also be responsible in designing the appropriate bench, on-human, and/or clinical studies to verify and validate these algorithms. This includes formulating comprehensive rationale for study population, methodology, and endpoints. You will assemble results from these studies and summarize them as appropriate in our regulatory submissions and defend them during interactions with said regulatory bodies.

EXPERIENCE REQUIREMENTS:

• Ph.D. 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 product development, preferably with experience in algorithm development, verification and validation, and/or regulatory affairs.
• Relevant experience working within a medical device Quality Management System (21 CFR 820), with working understanding of proper design control, document management, risk management, GMP/GCP, and product development lifecycle processes.
• 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, neurological, or others.
• 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.
• Excellent communication skills and the ability to work fully independently.

• Identify key concerns regarding safety and effectiveness of our medical device products.
• Collaborate with the verification and validations team to design studies that addresses these concerns of safety and effectiveness, including documenting the study design and their rationale in pre-submission/submission packages to US regulatory body.
• Independently prepare key components of regulatory submission packages, including summarizing various technical documentations.
• Improve our existing quality management system by introducing new processes as well as creating more operating procedures.
• Participate in QMS process reviews and development of project timelines.