Staff Systems Engineer, Wearable Medical Devices

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.

Position Responsibilities:

• 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.

 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.
• 6+ 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.

Additional Information

Disclosure of Trade Secrets

Samsung has a strict policy on trade secrets. In applying to Samsung and progressing through the recruitment process, you must not disclose any trade secrets of a current or previous employer.

Essential Job Functions

This position will be performed in an office setting. The position will require the incumbent to sit and stand at a desk, communicate in person and by telephone, and frequently operate standard office equipment, such as telephones and computers.

Samsung Research America is committed to complying with all Federal, State and local laws related to the employment of qualified individuals with disabilities. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact the recruiter or email sratalent@samsung.com.

Equal Employment Opportunity

At Samsung, we believe that innovation and growth are driven by an inclusive culture and a diverse workforce. We aim to create a global team where everyone belongs and has equal opportunities, inspiring our talent to be their true selves. Together, we are building a better tomorrow for our customers, partners, and communities.

Samsung Research America is committed to employing a diverse workforce, and  provide Equal Employment Opportunity for all individuals regardless of race, color, religion, gender, age, national origin, marital status, sexual orientation, gender identity, status as a protected veteran, genetic information, status as a qualified individual with a disability, or any other characteristic protected by law.

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