Senior Embedded Software Engineer, Medical Devices

Galvanize; Redwood City (CA); Sur place; USD 125 000 - 145 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

401(k)

Résumé du poste

Galvanize Therapeutics is seeking a Senior R&D Engineer, Software in the United States to contribute to the development of pulsed-field energy delivery electrosurgical devices. You will design, verify, and validate new technologies and ensure robust documentation and traceability throughout the product lifecycle.

Collaborating with R&D, Quality, Regulatory, Clinical, and Operations, you will develop software for embedded devices, maintain Design Control artifacts, and drive risk management per

Qualifications

• 5+ years designing software for Class II/III medical devices.
• Experience with ablation or energy delivery systems preferred.
• Strong embedded C/C++ development expertise.
• Familiarity with 21 CFR Part 820, ISO 13485, IEC 62304.
• Proven ability to document and trace design controls.

Responsabilités

• Prepare and present technical docs for stakeholders.
• Lead Software Design Control elements: SRS, SDS, DV protocols, test cases.
• Maintain ISO 14971 risk management docs for equipment and disposables.
• Manage Input/Output Trace Matrix linking requirements, risks, verification.
• Develop software for embedded devices and automated testing tools.
• Collaborate with R&D, Quality, Regulatory, Clinical, Operations.
• Lead design and risk reviews and test planning.
• Support DV testing coverage for requirements and risk mitigations.
• Update risk and design docs during changes or investigations.
• Ensure compliance with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304.

Connaissances

C/C++

Embedded software

RTOS

Python

Regulatory knowledge

Cybersecurity risk

Risk assessment

Documentation

Communication

Version control

Test automation

Formation

Engineering degree

Outils

Version control

Test automation

Description du poste

Galvanize Therapeutics is seeking a Senior R&D Engineer, Software in the United States to contribute to the development of pulsed-field energy delivery electrosurgical devices. You will design, verify, and validate new technologies and ensure robust documentation and traceability throughout the product lifecycle.

Collaborating with R&D, Quality, Regulatory, Clinical, and Operations, you will develop software for embedded devices, maintain Design Control artifacts, and drive risk management per