Senior Embedded Software Engineer, Medical Devices (R&D)

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

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

Disability Insurance

401(k)

Paid Time Off

Job summary

Galvanize Therapeutics is seeking 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 embedded systems and lead software design control tasks.

The role requires 5+ years in medical device software, C/C++, RTOS, Python, and strong regulatory knowledge (21 CFR Part 820, ISO 13485, IEC 62304).

Qualifications

• Scientific degree in Software, Computer, Electrical, or Biomedical Engineering with consideration given to degree level combined with experience.
• Experience with Class II/III medical devices, preferably in ablation or energy delivery systems.
• Embedded software design experience using C and C++.
• Experience with real-time operating systems in embedded software.
• Python or other scripting languages for data analysis.
• Knowledge of Software Design Control and Risk Management per 21 CFR Part 820, ISO 13485, IEC 62304.
• Experience with cybersecurity threat modeling, risk analysis and secure design practices.
• Proficiency in Risk Assessment Documents (FMEA) and risk analysis methodologies.
• Attention to detail and documentation traceability.
• Excellent communication and organizational skills; ability to manage multiple priorities.

Responsibilities

• Prepare and present clear, structured technical documentation and summaries for internal and external stakeholders.
• Lead the development, documentation, and maintenance of Software Design Control elements including Software Requirements Specifications, Software Design Specifications, Design Verification protocols, test cases, and reports
• Create and maintain Risk Management documentation in accordance with ISO 14971, including: Design, Use-Related, Process, and/or Software risk assessment for capital equipment and/or disposables.
• Manage and maintain the Input/Output Trace Matrix, ensuring accurate linking of requirements, risks, and verification/validation activities.
• Develop software for embedded devices, automated testing and supporting tools, ensuring that all design requirements are met.
• Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment across the product lifecycle.
• Participate in and/or lead formal design reviews, risk reviews, and test planning sessions.
• Develop input and oversight for Design Verification (DV) testing activities to ensure adequate coverage of product requirements and risk mitigations.
• Support updates to existing risk and design control documentation during design changes, sustaining engineering, or complaint investigations.
• Ensure compliance with applicable regulatory standards including 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304.
• Assist in continuous improvement of the design control and risk management processes to improve efficiency and compliance.

Skills

C

C++

Python

RTOS

Software design controls

Risk management

Regulatory compliance

Documentation & traceability

Communication

Education

Engineering degree

Job description

Galvanize Therapeutics is seeking 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 embedded systems and lead software design control tasks.

The role requires 5+ years in medical device software, C/C++, RTOS, Python, and strong regulatory knowledge (21 CFR Part 820, ISO 13485, IEC 62304).