Principal Software Engineer, New Indications

HistoSonics 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, HistoSonics 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):

HistoSonics 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 Engineering, Clinical, and Product Development teams to translate clinical and system requirements into software specifications.

• Define appropriate technology stacks and development frameworks for treatment planning and therapy delivery software.

• Evaluate new technologies, tools, and development methodologies to improve product quality and team effectiveness.

• Provide technical mentorship and guidance to software engineers and cross-functional stakeholders.

Project and Program Leadership

• Own software project plans, technical milestones, and deliverables aligned with overall program objectives.

• Identify technical risks, dependencies, and mitigation strategies.

• Coordinate activities with external software vendors and development partners, ensuring design control and DHF-compliant outputs.

• Communicate technical progress, risks, and recommendations to program leadership and executive stakeholders.

Required

Qualifications and Skills:

• Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, or a related field.

• 10+ years of software development experience, including at least 5 years developing software for regulated medical devices.

• Deep expertise in IEC 62304 and software development lifecycle processes for medical devices.

• Demonstrated hands-on experience authoring software compliance documentation, including SDP, SRS, software architecture descriptions, DFMEA, traceability matrices, and verification documentation.

• Direct experience with software risk management per ISO 14971.

• Proven experience leading software verification and validation activities across complex systems.

• Strong software architecture and system design expertise.

• Experience integrating AI tools into DevOps, Git, and Relyence (or similar).

• Project leadership experience managing technical deliverables in complex, cross-functional environments.

• Excellent written and verbal communication skills with the ability to produce regulatory-quality documentation and influence technical decisions across the organization.

Preferred

• Experience building medical device software processes from early-stage development through commercialization.

• Background in capital equipment, surgical, interventional, or image-guided therapy systems.

• Experience developing software in Python, C, and/or C++ within a regulated environment.

• Familiarity with real-time and embedded software architectures.

• Experience supporting FDA, EU MDR, and other global regulatory submissions for software-enabled medical devices.

• Demonstrated success serving as a technical lead, architect, or principal engineer on complex multidisciplinary product development programs.

Benefits

: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

U.S. Work Authorization & Sponsorship:

Employer will not sponsor visas for position.