Principal Software Engineer - Medical Device Compliance

HistoSonics, Inc.; Minneapolis, Saint Paul (MN, MN); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health, dental, vision insurance

Life and disability insurance

401(k) and PTO

Job summary

HistoSonics, Inc. is seeking a Principal Software Engineer to lead software compliance and drive new clinical indications from first-in-human studies through commercialization.

This role demands deep IEC 62304 expertise and a track record of managing software lifecycle artifacts across regulated medical devices. You will partner with Regulatory, Quality, and Clinical teams to shape architecture, ensure traceability, and deliver robust software for therapy delivery systems.

Qualifications

• 10+ years of software development experience, including 5+ years in regulated medical devices.
• Deep expertise in IEC 62304 and medical device lifecycle processes.
• Hands-on authoring of SDP, SRS, SAD, DFMEA, traceability matrices, and verification documentation.
• Experience with ISO 14971 risk management.
• Proven leadership in software verification, validation, and cross-functional collaboration.
• Experience integrating AI tools into DevOps, Git, and regulatory tooling.

Responsibilities

• Own IEC 62304 compliance activities and document lifecycle.
• Lead software risk management, hazard analysis, and DFMEA.
• Define and maintain SDP, SRS, SAD, and traceability.
• Collaborate with Regulatory Affairs, Quality, and cross-functional teams.
• Guide software verification, validation, and release processes.
• Mentor engineers and drive architecture and technology decisions.

Skills

IEC 62304

Regulated software

Technical leadership

Software architecture

Software lifecycle

DevOps integration

Python/C/C++

Regulatory risk management

Regulatory submissions

Education

Bachelor’s degree in Software Engineering or related field

Tools

Relyence

Job description

HistoSonics, Inc. is seeking a Principal Software Engineer to lead software compliance and drive new clinical indications from first-in-human studies through commercialization.

This role demands deep IEC 62304 expertise and a track record of managing software lifecycle artifacts across regulated medical devices. You will partner with Regulatory, Quality, and Clinical teams to shape architecture, ensure traceability, and deliver robust software for therapy delivery systems.