Looking for a Systems Design Engineer, responsible for developing and integrating software / hardware solutions and products related to medical device systems. System integration includes image/video processing software and hardware, GUI interfaces, and data transfer between all devices in the system.

Medical Device Level II expreience is required

Responsibilities

Lead development of complex medical instruments through all development phases from design input through verification and validation to manufacturing transfer stages and in coordination with overall system requirements;

Bachelor degree in related discipline, such as Computer Science, Electrical Engineering or related; master's degree is preferred.

Experience Requirements

Strong knowledge of US and global regulatory requirements for medical devices

A minimum of 5+ years in Software Engineering, with experience working with internal and external teams, development partners and suppliers within a company operated under ISO 13485 and FDA protocol in all phases from design input to transfer to production

Successful assembly of documentation to support rapid prototyping for pre-clinical and clinical studies.

Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366, is preferred.

Healthcare Interfaces Experience Preferred.

Strong background in object-oriented programming and strong understanding of using design patterns.

Demonstrated proficiency and fundamental knowledge of Microsoft technologies such as .NET Core, and .NET Framework.

Experience with service-oriented architecture (SOA) and development of containerized applications.