Senior R&D Engineer, Software

Galvanize; 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 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.

Responsibilities

• 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.

Skills

C/C++

Embedded software

RTOS

Python

Regulatory knowledge

Cybersecurity risk

Risk assessment

Documentation

Communication

Version control

Test automation

Education

Engineering degree

Tools

Version control

Test automation

Job description

About Galvanize Therapeutics

Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.

About Galvanize Therapeutics

Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.

About The Role

The Senior R&D Engineer, Software will contribute to the development of new pulsed-field energy delivery electrosurgical devices. This role includes technical contribution to the design and development projects and execution of product verification and validation testing.

Qualifications

Education and Training:

• Scientific degree in Software, Computer, Electrical, or Biomedical Engineering with consideration given to degree level combined with experience. Other degrees within the engineering discipline are acceptable with medical device experience.

Skills And Experience

• 5+ years of progressive experience in the design and development of software for Class II/III medical devices, preferably in ablation or energy delivery systems.
• Proficiency in embedded software designs using C and C++ programming languages.
• 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
• Proficient in authoring Risk Assessment Documents (e.g., Failure Mode and Effect Analysis Documents) and understanding risk analysis methodologies.
• Strong attention to detail with a systematic approach to documentation and traceability.
• Excellent communication and organizational skills; ability to manage multiple priorities.

What You'll Do

• 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.

This role pays betwee n $125,000 and $145,000 p er year, and your actual base pay will depend on your location, skills, qualifications, and experience.

Galvanize offers a robust benefits package to full-time employees, including medical, dental, and vision coverage, life insurance, short- and long-term disability protection, 401(k), and flexible paid time off.

Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.