Medical Device Product Development and Regulatory Affairs Engineer

Title: Medical Device Product Development and Regulatory Affairs Engineer

Company: Samsung Research America (SRA)

Lab: Health (MPS)

Location: Mountain View, CA

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!

Role Purpose:

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 Staff Engineer, you will be guiding software-as-a-medical-device (SaMD) projects on strategy and decision making toward successful regulatory submissions and clearances. This includes the ability to understand physiological data and design studies to verify the validity of the data. You will also be instrumental in driving the team to a consensus on safety and effectiveness considerations for our products. You will document these considerations in our regulatory submissions and defend them during interactions with said regulatory bodies.

With your prior experience, you will also have the opportunity to contribute to the refinement of our Quality Management System (QMS) processes such as design controls, documentation management, traceability, and risk management.

Major Responsibilities:

• Identify key concerns regarding safety and effectiveness of our SaMD products.
• Collaborate with an experienced interdisciplinary team to address and document said concerns throughout the product development cycle.
• Collaborate with our verification and validation teams to define appropriate, comprehensive, and innovate methods to test our products.
• Prepare 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.

Qualifications:

• Master’s/PhD Degree in a relevant Science or Engineering field (PhD preferred) or equivalent combination of education, training, and experience.
• 6+ years of relevant experience in medical device research or product development, preferably with experience in algorithm development, verification and validation, and/or regulatory affairs.
• A minimum of 2 years of 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.
• Basic understanding of statistics.

Our total rewards programs are designed to motivate and engage exceptional talent. The base pay range for roles at this level is $121,200 and $166,550 but may be higher or lower in other states due to geographic differentials in the labor market. Within the base pay range, individual rates depend on a number of factors—including the role’s function and location as well as the individual’s knowledge, skills, experience, education and training. This is part of our comprehensive compensation package with annual bonus eligibility and generous benefits to help you live life well.

Regular full-time employees (salaried or hourly) have access to benefits including: Medical, Dental, Vision, Life Insurance, 401(k), Employee Purchase Program, Tuition Assistance (after 6 months), Paid Time Off, Student Loan Program (after 6 months), Wellness Incentives, and many more.  In addition, regular full-time employees (salaried or hourly) are eligible for MBO bonus compensation, based on company, division, and individual performance.

 

Additional Information

Essential Job Functions

This position will be performed in an office setting. The position will requ