Senior Software Systems Analyst

HISTOSONICS•Plymouth, MN

20d•Hybrid

About The Position

The Senior Software Systems Analyst serves as a liaison between stakeholders and development teams, gathering, analyzing, and documenting software requirements. The role translates business needs into clear technical specifications so developers can deliver software that meets user needs and business objectives. The analyst develops a deep understanding of the HistoSonics system, including subsystem interactions and how Edison software interacts with those subsystems, while ensuring development aligns with the product vision and company goals. The position works closely with cross-functional teams, including R&D, Quality, Manufacturing, Field Service, and Regulatory Affairs. It supports requirements-based software development and quality assurance, contributes to risk identification and traceability, and maintains awareness of medical-device standards and design-control requirements. The role is based in Plymouth, Minnesota, or Ann Arbor, Michigan, with a hybrid work arrangement and approximately 10% travel.

Requirements

Bachelor’s degree in Computer Science, Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline.
At least 5 years of experience in a regulated industry or medical-device development.
Excellent verbal and written communication skills, including the ability to translate technical information for non-technical stakeholders.
Proficiency in creating clear and concise software requirements documents, use cases, and user stories.
Ability to work effectively in cross-functional teams and bridge technical and non-technical groups.
Expertise in hardware-software integration for medical devices.
Strong understanding of software development methodologies.
Familiarity with software development tools such as Microsoft DevOps.
Solid knowledge of medical-device regulatory frameworks, including ISO 13485 and ISO 14971.

Responsibilities

Create detailed specifications, user stories, functional requirements, and use cases for technical and non-technical audiences.
Analyze business needs and processes, identify gaps, and assess the feasibility of potential solutions.
Bridge business stakeholders and development teams to ensure requirements are clearly understood.
Support developers by ensuring requirements are understood and implemented correctly.
Develop a deep understanding of the HistoSonics system, its subsystems, and the interactions between Edison software and those subsystems.
Ensure software development efforts align with the product vision and company goals.
Analyze existing software systems to identify opportunities for improvement, optimization, and feature integration.
Collaborate with R&D, Quality, Manufacturing, Field Service, and Regulatory Affairs.
Work with quality assurance teams to develop test cases, scenarios, and test plans based on documented requirements.
Collaborate with risk management to identify, document, and trace risks to requirements and implementation.
Review and validate software functionality against specified requirements as part of quality assurance.
Stay current with industry trends, best practices, and emerging technologies to recommend process improvements and innovative solutions.
Maintain awareness of relevant medical-device standards, including IEC 62304 and ISO 14971, and design-control requirements.