Senior R&D Engineer, Software

Galvanize; Redwood City (CA); Presencial; USD 125.000 - 145.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision

Life Insurance

Disability Insurance

401(k)

Paid Time Off

Descripción de la vacante

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).

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

C

C++

Python

RTOS

Software design controls

Risk management

Regulatory compliance

Documentation & traceability

Communication

Educación

Engineering degree

Descripción del empleo

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.

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.