Senior R&D Engineer, Software

Galvanize•Redwood City, CA

17h•$125,000 - $145,000

About The Position

The Senior R&D Engineer, Software contributes to the development of new pulsed-field energy delivery electrosurgical devices. The role involves technical contributions to design and development projects and execution of product verification and validation testing. The engineer develops embedded-device software, automated testing, and supporting tools, while maintaining design-control and risk-management documentation and supporting regulatory alignment across the product lifecycle.

Requirements

Scientific degree in Software, Computer, Electrical, or Biomedical Engineering; degree level may be considered together with experience. Other engineering degrees are acceptable with medical-device experience.
At least 5 years of progressive experience designing and developing software for Class II/III medical devices, preferably in ablation or energy-delivery systems.
Proficiency in embedded software design using C and C++.
Experience with real-time operating systems used in embedded software.
Expertise in Python or other scripting languages for data analysis.
Strong knowledge of Software Design Control and Risk Management requirements under 21 CFR Part 820, ISO 13485, and IEC 62304.
Experience with cybersecurity threat modeling, risk analysis, and secure design practices.
Proficiency authoring risk assessment documents, such as Failure Mode and Effect Analysis documents, and understanding risk-analysis methodologies.
Strong attention to detail and a systematic approach to documentation and traceability.
Excellent communication and organizational skills, with the ability to manage multiple priorities.

Responsibilities

Prepare and present clear, structured technical documentation and summaries for internal and external stakeholders.
Lead 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 ISO 14971 Risk Management documentation, including design, use-related, process, and/or software risk assessments for capital equipment and/or disposables.
Manage and maintain the Input/Output Trace Matrix, linking requirements, risks, and verification/validation activities.
Develop software for embedded devices, automated testing, and supporting tools to meet design requirements.
Collaborate with R&D, Quality, Regulatory, Clinical, and Operations teams to support cohesive development and regulatory alignment throughout the product lifecycle.
Participate in and/or lead formal design reviews, risk reviews, and test-planning sessions.
Develop input for and provide oversight of Design Verification testing activities to ensure adequate coverage of product requirements and risk mitigations.
Support updates to 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 improving design-control and risk-management processes for efficiency and compliance.