Senior R&D Engineer, Software

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.

Pay and benefits

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.