Principal Software Engineer - Medical Device Compliance

HISTOSONICS INC; Plymouth (MN); On-site; USD 150,000 - 175,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Job summary

HistoSonics in Plymouth, MN seeks a Principal Software Engineer to lead software compliance and architecture for new indications. You will own the SDP, SRS, DFMEA, and lifecycle documentation, aligning development with IEC 62304 and regulatory expectations.

As a strategic technical leader, you will coordinate with Regulatory, Quality, and Therapy teams to advance clinical applications while guiding engineers through design controls and robust software delivery.

Qualifications

• Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, or related field.
• 10+ years in software development, 5+ years in regulated medical devices.
• Strong IEC 62304 expertise and lifecycle documentation experience.

Responsibilities

• Lead IEC 62304 compliance and documentation development.
• Own software risk management per ISO 14971 and IEC 62304.
• Define architecture, roadmaps, and technology stacks.
• Mentor engineers; guide cross-functional teams on compliance.
• Oversee software verification, validation, and release processes.
• Collaborate with Regulatory, Quality, and Therapy teams.

Skills

IEC 62304

Regulatory compliance

Software architecture

DevOps integration

Python

C++

Leadership

Team mentorship

Regulatory submissions

Software safety

Education

Bachelor's degree in software/engineering

Tools

Relyence

Git

Job description

HistoSonics in Plymouth, MN seeks a Principal Software Engineer to lead software compliance and architecture for new indications. You will own the SDP, SRS, DFMEA, and lifecycle documentation, aligning development with IEC 62304 and regulatory expectations.

As a strategic technical leader, you will coordinate with Regulatory, Quality, and Therapy teams to advance clinical applications while guiding engineers through design controls and robust software delivery.