Staff Digital Systems Engineer (Andover, MA)

Smith & Nephew•Andover, MA

1d•Hybrid

About The Position

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you ready to lead the design of next generation connected medical systems that truly make a difference? As a Staff Digital Systems Engineer within our Advanced Wound Management R&D team, you will play a pivotal role in shaping cloud connected, wearable and digital health solutions from early concept through launch. This is a highly visible technical leadership role where your expertise will directly impact patient outcomes and the future of digitally enabled care.

Requirements

A B.S. in Computer Science, Computer Engineering, Electrical Engineering or a related technical field, with an M.S. preferred
6+ years of related experience with a B.S.
3+ years of related experience with an M.S.
Significant experience delivering complex medical device or regulated products, including connected or cloud enabled systems
Strong systems engineering expertise, including requirements management, system architecture and design controls
In depth knowledge of medical device regulations and standards such as IEC 62304, ISO 14971, IEC 60601 and FDA or EU MDR
Experience with cloud platforms such as AWS, Azure or GCP, including security, networking and data considerations
The ability to lead technically across disciplines, communicate clearly and drive outcomes in a collaborative environment

Responsibilities

Leading end to end system level design for connected medical devices, spanning device hardware, firmware, mobile applications, cloud services and data platforms
Translating user needs and stakeholder inputs into clear, testable system requirements and architectures
Owning system requirements development, including user needs, design inputs and interface specifications
Defining cloud connected system interfaces, data flows, APIs and interoperability requirements
Partnering with software, cloud and cybersecurity teams to define non functional requirements such as availability, scalability, security and privacy
Driving cybersecurity and privacy engineering activities including threat modeling, security requirements and regulatory documentation
Developing system verification and validation strategies for complex, regulated medical systems
Supporting system integration, risk management activities and issue resolution across cross functional teams
Contributing to pre clinical and clinical evaluations through protocol input and technical troubleshooting as needed