Senior Software Systems Analyst

HistoSonics • Plymouth, MN

62d • Hybrid

About The Position

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.

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 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.

Responsibilities

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 101-250 employees