Principal Software Engineer: MedTech for New Indications

HistoSonics, Inc.; Plymouth (MN); Hybrid; USD 150,000 - 175,000; Full time

Job summary

HistoSonics, Inc. in Plymouth, MN, is seeking a Principal Software Engineer for New Indications to lead software compliance strategy and development for emerging clinical applications.

You will own regulatory lifecycle documentation and ensure IEC 62304 alignment from prototype to commercialization, partnering with Regulatory Affairs and Quality. This highly influential individual contributor role shapes software architecture, cybersecurity, and technology roadmaps for future indications across

Qualifications

• Bachelor's degree in Software Engineering, CS, EE, or related field.
• 10+ years software development experience, including 5+ years in regulated medical devices.
• Deep expertise in IEC 62304 and medical device software lifecycle processes.
• Experience authoring compliance documentation: SDP, SRS, SAD, DFMEA, traceability matrices, verification docs.
• Experience with software risk management per ISO 14971.
• Experience leading software verification and validation across complex systems.
• Strong software architecture and design skills.
• Experience integrating AI tools into DevOps, Git, and Relyence or similar.
• Proven project leadership delivering technical deliverables in cross-functional environments.
• Excellent written and verbal communication for regulatory-quality docs.

Responsibilities

• IEC 62304 compliance and documentation: define compliance plans and own lifecyle docs.
• Risk, test, and verification leadership: manage risk analyses and verification plans.
• Technical leadership and software architecture: define architecture and lead tech decisions.
• Project and program leadership: own plans, milestones, and cross-functional coordination.

Skills

Regulated medical devices

IEC 62304

Software lifecycle

Software architecture

DevOps with AI tools

C/C++ in regulated env

Education

Bachelor's degree in Software Engineering/CS/EE

Tools

Relyence

Git

Python

C++

Job description

HistoSonics, Inc. in Plymouth, MN, is seeking a Principal Software Engineer for New Indications to lead software compliance strategy and development for emerging clinical applications.

You will own regulatory lifecycle documentation and ensure IEC 62304 alignment from prototype to commercialization, partnering with Regulatory Affairs and Quality. This highly influential individual contributor role shapes software architecture, cybersecurity, and technology roadmaps for future indications across