Senior Software Systems Analyst

Overview

Histo Sonics, Inc. is a medical device company founded in 2009 that has developed a non‑invasive sonic beam therapy platform using histotripsy, capable of destroying targeted liver tumors. Our mission is to advance the science of histotripsy and bring transformational change to physicians and patients.

Location: Plymouth, MN (Hybrid)

Travel Expectation: Approximately 25% – visit other Midwest sites, typically 1× per month for 2–3+ days.

Pay Range: $/yr – $/yr

Sr. Software Systems Analyst – act as a liaison between stakeholders and development teams to gather, analyze, and document software requirements. Translate business needs into clear technical specifications, ensuring the final product meets user needs and business objectives.

• 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 Histo Sonics system, its subsystems, and how the Edison software interacts with them.
• 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 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.

• 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 devices.
• Strong understanding of software development methodologies.
• Familiarity with software development tools (e.g., Microsoft Dev Ops).
• Solid knowledge of medical device regulatory frameworks, including ISO 13485 and ISO 14971.

• Comprehensive benefits package including health, dental, and vision insurance.
• Life, short‑term, and long‑term disability insurance.
• 401(k) retirement plan.
• Paid time off, including paid maternity and paternity leave.
• Disability insurance.
• Additional benefits as outlined in the employee handbook.

• Seniority level: Mid‑Senior level
• Employment type: Full‑time
• Job function: Information Technology and Engineering
• Industries: Medical Equipment Manufacturing

Histo Sonics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

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.