Principal Software Engineer, Indications

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Full Time Professional Plymouth, MN, US

3 days ago Requisition

Salary Range: $ To $ Annually

Histo Sonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, Histo Sonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.

We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.

Location :
Plymouth, MN

Position Summary (Why this role matters):

Histo Sonics is expanding the power of histotripsy into new indications across the body. The Principal Software Engineer will serve as the technical leader for software development and regulatory compliance across emerging clinical applications. This role will own the software compliance strategy and lead the development of software systems that take new indications from first-in-human studies through commercialization. This will include assessing prototype software against IEC 62304, establishing compliant development plans, author, and overseeing key software lifecycle documentation.

Position Summary (Why this role matters):

As a key strategic partner to cross-functional teams, the Principal Software Engineer will help advance targeted clinical applications and support successful product launches across multiple anatomical areas, including but not limited to neurological, abdominal, and women’s health indications. This is a highly influential individual contributor role with significant impact on technology strategy, software quality, and product development execution.

Key Responsibilities (What you’ll do):

IEC 62304 Compliance and Documentation

• Assess software against IEC 62304 requirements; define software safety classifications and perform gap analyses.
• Author and own the Software Development Plan (SDP), establishing development methodology, configuration management, version control, review, and release processes.
• Create and maintain the Software Requirements Specification (SRS), Software Architecture Description (SAD), and software-level DFMEA in accordance with design controls.
• Develop and maintain requirements-to-implementation traceability across the software lifecycle.
• Partner with Regulatory Affairs and Quality teams to ensure software documentation meets global submission requirements.
• Serve as the subject matter expert for software lifecycle compliance and design control activities.

Risk, Test, and Verification Leadership

• Own software risk management activities per ISO 14971 and IEC 62304, including hazard analysis, DFMEA, and risk control implementation.
• Define and maintain Software Verification and Validation Plans.
• Establish traceability between requirements, test protocols, and objective evidence.
• Lead the review of software test strategies across unit, integration, and system-level verification activities.
• Guide defect management, regression testing, and software release qualification processes.
• Collaborate with Safety and Human Factors teams to ensure use-related software risks are identified and mitigated.

Technical Leadership and Software Architecture

• Define software architecture and technical roadmaps supporting future indications and product evolution.
• Lead critical technical decisions regarding software design, scalability, maintainability, and cybersecurity.
• Collaborate with Therapy Physics, Systems…