Systems Verification Engineer

Smith+Nephew•Andover, MA

4d•$85,750 - $128,750•Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you passionate about quality, systems thinking and delivering safe, high performing medical devices that truly change lives? As a Systems Verification Engineer within our Sports Medicine business, you will play a critical role in ensuring our innovative technologies meet the highest standards of performance, reliability and regulatory compliance. This is an exciting opportunity to work at the intersection of hardware, software and systems engineering, partnering with talented teams to bring new products from concept to market in a hybrid role based in Andover, MA.

Requirements

Bachelor’s degree in Electrical, Biomedical or Computer Engineering or a related field
3 or more years of relevant experience in systems verification, test engineering or product development
Strong experience verifying complex electromechanical systems that include hardware and software
Knowledge of medical device standards and regulations including IEC 62304, ISO 14971, IEC 60601 and FDA design controls
Experience with test automation and scripting using languages such as C, C plus plus, C sharp, Java, Python, JavaScript, MATLAB or LabVIEW
Strong problem-solving skills, attention to detail and the ability to collaborate effectively across functions

Nice To Haves

Desirable experience working in the medical device industry or another regulated environment

Responsibilities

Lead system verification activities for medium to large scale new product development projects within Sports Medicine
Own verification planning and execution including test strategies, protocols, test cases, traceability matrices and summary reports
Partner closely with Systems Engineering, R&D and Program Management to align testing with project timelines and priorities
Plan, develop and execute manual and automated software testing based on product risk and intended use
Identify, track and support resolution of hardware and software defects using defect management tools such as JIRA
Support requirements definition and traceability by translating system and software requirements into robust verification approaches
Coordinate and support testing with external laboratories including safety, EMI EMC, environmental and transportation testing
Participate in design and requirements reviews and support documentation required for FDA submissions
Support risk management activities including Software FMEA in accordance with ISO 14971, IEC 62304 and IEC 80002 1
Create, validate and maintain test automation platforms and test stands