Principal Software Engineer, New Indications
About The Position
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. 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.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
- 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.
- 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.
- 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.
Benefits
- health, dental, and vision insurance
- life, short-term and long-term disability insurance
- 401(k)
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Principal
