Senior Embedded Software Engineer - Medical Devices

Galvanize Therapeutics; Redwood City (CA); On-site; USD 125,000 - 145,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

Galvanize Therapeutics seeks a Senior R&D Engineer, Software to contribute to the development of pulsed-field energy delivery electrosurgical devices. You will design, develop, and verify software for Class II/III medical devices and drive risk management and regulatory alignment across the product lifecycle.

You will collaborate with R&D, Quality, Regulatory, Clinical, and Operations teams, lead design reviews, and ensure documentation and traceability meet 21 CFR Part 820, ISO 13485, and IEC

Qualifications

• 5+ years in software design for Class II/III medical devices.
• Embedded C/C++ with RTOS experience.
• Knowledge of 21 CFR Part 820, ISO 13485, IEC 62304.

Responsibilities

• Prepare technical documentation and summaries for internal and external stakeholders.
• Lead Software Design Control activities: SRS, SDS, DV protocols, test cases and reports.
• Create and maintain ISO 14971 risk management documentation for capital equipment and disposables.
• Manage Input/Output Trace Matrix linking requirements, risks and verifications.

Skills

C/C++

RTOS

Python

Regulatory knowledge

FMEA

Documentation

Cross-functional

Embedded software

Education

Engineering degree

Job description

Galvanize Therapeutics seeks a Senior R&D Engineer, Software to contribute to the development of pulsed-field energy delivery electrosurgical devices. You will design, develop, and verify software for Class II/III medical devices and drive risk management and regulatory alignment across the product lifecycle.

You will collaborate with R&D, Quality, Regulatory, Clinical, and Operations teams, lead design reviews, and ensure documentation and traceability meet 21 CFR Part 820, ISO 13485, and IEC