Senior Software Systems Analyst

About HistoSonics

Location and work arrangement

• The role is hybrid and based in Plymouth, Minnesota, or Ann Arbor, Michigan.
• Travel expectation is approximately 10%.

Role overview

Responsibilities

• Create specifications, user stories, functional requirements, and use cases; analyze processes, identify gaps, and assess solution feasibility.
• Bridge stakeholders and developers, help ensure requirements are implemented, and align development with product vision.
• Understand the Edison system and its subsystem interactions; analyze existing software for improvements, optimization, and integrations.
• Collaborate with R&D, Quality, Manufacturing, Field Service, and Regulatory Affairs.
• Develop test plans with QA, support risk identification and traceability, and validate software against requirements.
• Keep current with industry practices and technologies; maintain awareness of medical device standards and design controls.

Qualifications

• Bachelor's degree in Computer Science, Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline.
• 5+ years of experience in a regulated industry or medical device development.
• Excellent written and verbal communication, including translating technical information for non-technical stakeholders.
• Proficiency creating software requirement documents, use cases, and user stories; ability to work across technical and non-technical teams.
• Expertise in medical-device hardware-software integration and strong understanding of software development methodologies.
• Familiarity with tools such as Microsoft DevOps.
• Knowledge of medical device frameworks including ISO 13485 and ISO 14971.

Standards and design controls

• Relevant standards include IEC 62304 and ISO 14971; the role maintains awareness of design control requirements.

Benefits

• Full-time benefits include health, dental, and vision insurance, life and disability insurance, a 401(k), and paid time off.

Work authorization

• The employer will not sponsor visas for this position.