Staff Systems Engineer, Wearable Medical Devices

Samsung - Mountain View, CA

Full-time - Senior

Mountain View, CA

Merchant Wholesalers, Durable Goods

About the position

As a Staff Systems Engineer at Samsung, you will play a crucial role in guiding medical device projects through appropriate development and regulatory strategies, ensuring successful regulatory clearances and product launches. You will collaborate with a cross-functional team to ensure that products are designed, developed, manufactured, and tested in compliance with global medical device regulations. Your expertise in physiological signals and algorithms will be essential in designing studies to verify and validate these algorithms, contributing to the next generation of consumer health products and service experiences.

Responsibilities

• Identify key concerns regarding safety and effectiveness of medical device products.
• Collaborate with the verification and validations team to design studies addressing safety and effectiveness concerns.
• Document study design and rationale in pre-submission/submission packages to US regulatory bodies.
• Independently prepare key components of regulatory submission packages, summarizing various technical documentation.
• Improve the existing quality management system by introducing new processes and creating operating procedures.
• Participate in QMS process reviews and development of project timelines.

Requirements

• Ph.D. in a relevant Science or Engineering field, such as Biomedical Engineering, Electrical Engineering, or 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 a working understanding of 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.
• Strong experience in at least one physiological domain (e.g., cardiovascular, endocrine, neurological) and capable of transitioning between different medical devices.
• 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.

Nice-to-haves

• Experience in algorithm development for medical devices.
• Familiarity with global medical device regulations and compliance standards.

Benefits

• Health insurance coverage
• Flexible scheduling options
• Professional development opportunities
• Paid holidays
• Wellness programs