Senior MedTech Software Systems Analyst (Hybrid)

HistoSonics, Inc.

Fort Snelling Unorganized Territory (MN)

Hybrid

USD 110,000 - 150,000

Full time

6 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Benefits offered by this job

Health, dental & vision insurance

401(k) with company match

Paid time off

Disability insurance

Job summary

HistoSonics, Inc. is seeking a Sr. Software Systems Analyst to translate business needs into technical requirements for the Edison software and related subsystems. You will liaise between stakeholders and development teams to ensure specifications meet user needs and align with product goals.

You will collaborate with R&D, Quality, Manufacturing, Field Service, and Regulatory Affairs, driving documentation, test planning, risk tracing, and integration efforts across the system architecture.

Qualifications

Bachelor’s degree in relevant field.
5+ years in regulated medical device development.
Excellent verbal and written communication to translate technical info.
Proficiency in creating clear software requirements, use cases, and user stories.
Experience with hardware–software integration for medical devices.

Responsibilities

Create detailed specifications, user stories, functional requirements, and use cases for technical and non-technical audiences.
Analyze business needs, identify gaps, and evaluate feasible solutions.
Bridge between stakeholders and development teams to ensure clarity of requirements.
Support developers by ensuring requirements are understood and implemented correctly.
Develop deep understanding of the HistoSonics system and Edison software interactions.
Ensure development efforts align with product vision and company goals.
Conduct in-depth analysis of existing software systems for improvements and new features.
Collaborate with R&D, Quality, Manufacturing, Field Service, and Regulatory Affairs.
Design test cases, scenarios, and plans with QA based on documented requirements.
Assist risk management to document and trace risks to requirements.
Participate in QA by validating software functionality against requirements.
Stay updated on industry trends and emerging technologies.
Maintain awareness of IEC 62304? IEC references: IEC 62304, ISO 14971; design control requirements.