Clinical Engineer
AnimaSalary not specified
Full Time
Junior (1 to 2 years)
Staff Engineer, Clinical Systems at Samsung Research America
Mountain View, California, United States
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Digital Health, TechnologyIndustries
Requirements
- 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
- Strong experience in at least one, and 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 device Quality 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
Responsibilities
- Identify key concerns regarding safety and effectiveness of SaMD products
- Collaborate with the verification and validation team to design studies that address these concerns of safety and effectiveness
- Document study design and their rationale in pre-submission/submission packages to US regulatory body
- Assess verification and validation documents in regulatory submission packages for US and other global regulatory agencies; work with the FDA as well as global Samsung team to achieve device clearances
- Participate in QMS process reviews and development of project timelines
- Guide SaMD projects on appropriate clinical study strategy that contributes toward successful regulatory submissions and clearances
- Understand scientific principles of various physiological signals and algorithms that utilize them
- Design appropriate bench, on-human, and/or clinical studies to verify and validate SaMD algorithms, including formulating comprehensive rationale for study population, methodology, and endpoints
- Work closely with clinical operations team in delivering quality study reports
- Assemble study reports and summarize them as appropriate in regulatory submissions and defend them during interactions with regulatory bodies
Skills
SaMD
Clinical Study Design
Regulatory Submissions
Physiological Signals
Algorithm Validation
Clinical Trials
Study Endpoints
AI
GenAI
Clinical Operations
Samsung Research America
Develops advanced technology in multiple domains
About Samsung Research America
Samsung Research America specializes in advanced technologies such as next-generation communications, artificial intelligence, digital media, mobile platforms, and digital health. Their innovations include FadeNet, a convolutional neural-network based technology, and the ECG Monitor App, which enables ECG recording using Galaxy Watch for atrial fibrillation screening.
665 Clyde Ave, Mountain View, CA 94043, USAHeadquarters
1988Year Founded
VENTURE_UNKNOWNCompany Stage
HardwareIndustries
501-1,000Employees
Benefits
Onsite Fitness Facility
Subsidized Meals
Coffee Barista Bar
Samsung University
Product Discounts
Dog Friendly Campus
Wellness Programs
Activity Clubs
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