Senior Software Systems Analyst

HistoSonics, Inc.; Fort Snelling Unorganized Territory (MN); Hybrid; USD 110,000 - 150,000; Full time

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.

Skills

Software requirements

Cross-functional collaboration

Stakeholder communication

Regulatory knowledge

Microsoft DevOps

Medical device software

Education

Bachelor’s degree in CS/Engineering or related

Tools

Microsoft DevOps

Job description

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.

We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.

Location

Plymouth, MN or Ann Arbor, MI - Hybrid

Travel Expectation

Approximately 10%

Position Summary (Why This Role Matters)

Sr. Software Systems Analyst position involves acting as a liaison between stakeholders and development teams to gather, analyze, and document software requirements. The role requires translating business needs into clear technical specifications for developers, ensuring the final product meets user needs and business objectives.

Key Responsibilities (What You’ll Do)

• Create detailed specifications, user stories, functional requirements, and use cases in clear, readable documents for both technical and non-technical audiences.


• Analyze business needs and processes, identify gaps, and determine feasibility of potential solutions.


• Serve as a bridge between business stakeholders and development teams to ensure clear understanding of requirements.


• Support developers by ensuring requirements are understood and correctly implemented in the software.


• Develop a deep understanding of the HistoSonics system, understand the interactions between all the subsystems and understand how the Edison software interacts with each of the subsystems.


• Ensure the software development efforts align with the overall product vision and company goals.


• Conduct in-depth analysis of existing software systems, identifying areas for improvement, optimization, and integration of new features.


• Collaborate closely with cross-functional teams including R&D, Quality, Manufacturing, Field Service, and Regulatory Affairs.


• Collaborate with quality assurance teams to design test cases, scenarios, and test plans based on documented requirements.


• Collaborate with risk management to help identify, document and trace risks to requirements and implementation.


• Participate in the quality assurance process by reviewing and validating software functionality against specified requirements.


• Stay up to date with industry trends, best practices, and emerging technologies to suggest process improvements and innovative solutions.


• Maintain awareness of relevant medical device standards (e.g., IEC 62304, ISO 14971) and design control requirements.

Qualifications And Skills

• Bachelor’s degree in Computer Science, Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering or related discipline.


• 5+ years of experience in regulated industry or medical device development.


• Excellent verbal and written communication skills with the ability to translate technical information to non-technical stakeholders.


• Proficiency in creating clear and concise software requirement documents, use cases, and user stories.


• Ability to work effectively in cross-functional teams, bridging the gap between technical and non-technical team members.


• Expertise in hardware-software integration for medical device.


• Strong understanding of software development methodologies.


• Familiarity with software development tools (e.g. Microsoft DevOps).


• Solid knowledge of medical device regulatory frameworks, including ISO 13485 and ISO 14971.

Benefits

We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

U.S. Work Authorization & Sponsorship

Employer will not sponsor visas for position.