Senior Software Manager - Regulated MedTech & Compliance

HistoSonics, Inc.; Plymouth (MN); On-site; USD 175,000 - 200,000; Full time

Benefits offered by this job

Health, dental, vision insurance

401(k)

Paid time off

Job summary

HistoSonics, Inc. is seeking a Sr. Software Manager to drive compliance for software across new indications.

You will own the Software Development Plan, SDP, and risk management activities, partnering with regulatory and therapy teams to enable first-in-human to commercialization for multiple indications. The role currently focuses on individual contributor duties with the potential to build and lead a software team as the program expands.

Qualifications

• Bachelor's or Master's degree in software engineering, computer science, electrical engineering, or a related field.
• 10+ years of software development experience, with 5+ years in regulated medical devices.
• Experience authoring IEC 62304 compliance documentation (SDP, SRS, architecture description, DFMEA, trace matrix).
• Experience with ISO 14971 risk management and software hazard analysis.
• Proven software verification and validation leadership, including protocol writing and defect management.
• Experience with AI integration in DevOps, Git, and Relyence or similar tools.

Responsibilities

• Own IEC 62304 compliance and documentation, including SDP, SRS, architecture description, and DFMEA.
• Lead software risk management per ISO 14971 and ensure traceability from requirements to tests.
• Manage software verification, validation planning, and defect management; oversee test protocols across levels.
• Own the software workstream plan, milestones, and external contractor coordination.
• Mentor engineers, establish scalable processes, and guide architecture for real-time/embedded software.

Skills

Software development

Regulated medical devices

IEC 62304

Software risk mgmt

Software verification

Regulatory documentation

AI in DevOps

Git

Relyence

Project management

Team leadership

Medical device software

Regulatory-quality docs

Education

Bachelor's or Master's in software/engineering

Tools

Python

C

C++

Git

Relyence

Job description

HistoSonics, Inc. is seeking a Sr. Software Manager to drive compliance for software across new indications.

You will own the Software Development Plan, SDP, and risk management activities, partnering with regulatory and therapy teams to enable first-in-human to commercialization for multiple indications. The role currently focuses on individual contributor duties with the potential to build and lead a software team as the program expands.