Senior Embedded Medical Device Architect (Hybrid)

GlobalLogic Inc.; Stati Uniti; Ibrido; USD 145.000 - 155.000; Tempo pieno

Descrizione del lavoro

GlobalLogic Inc. in Waltham, MA is seeking a Principal Medical Device Embedded Software Engineer to lead architecture, design, and implementation of embedded software for regulated medical devices in a hybrid role.

You will collaborate with Systems, Electrical, QA, Regulatory Affairs, and Manufacturing teams to drive safe, compliant software across the lifecycle. The role emphasizes technical ownership, risk management, Design History File contribution, and cross-functional influence in a

Competenze

• Extensive embedded software development experience in regulated environments.
• Experience with IEC 62304, ISO 13485, ISO 14971, FDA Design Controls.
• Experience in design controls and software lifecycle for medical devices.
• Strong analytical and problem-solving skills.

Mansioni

• Lead architecture, design, implementation, integration, and maintenance of embedded software for regulated medical devices.
• Collaborate with Systems, Electrical, QA, Regulatory Affairs, Manufacturing, and other cross-functional teams.
• Support regulatory submissions and audits and contribute to Design History File documentation.
• Produce and review software development plans, requirements, architecture, detailed designs, test documentation, and release records.

Conoscenze

C/C++

Embedded Linux/RTOS

Multithreaded real-time design

Device drivers & HAL

Hardware-software integration

Debugging complex systems

Requirements & verification

English communication

Formazione

Bachelor’s or Master’s degree in Computer Science/Engineering

Strumenti

JTAG

Oscilloscopes

Logic analyzers

Protocol analyzers

CI/CD pipelines

Cross-compilation toolchains

Descrizione del lavoro

GlobalLogic Inc. in Waltham, MA is seeking a Principal Medical Device Embedded Software Engineer to lead architecture, design, and implementation of embedded software for regulated medical devices in a hybrid role.

You will collaborate with Systems, Electrical, QA, Regulatory Affairs, and Manufacturing teams to drive safe, compliant software across the lifecycle. The role emphasizes technical ownership, risk management, Design History File contribution, and cross-functional influence in a