Senior Software Systems Analyst (Medtech)

Location: Hybrid in Plymouth, Minnesota or Ann Arbor, Michigan, United States. Approximately 10% travel expected.

Salary: $135,000–$160,000 annually

Company

Commercial-stage medtech company developing the Edison System, a non-invasive sonic beam therapy platform based on histotripsy.

What you will do

• Create software specifications, user stories, functional requirements, and use cases for technical and non-technical audiences.
• Analyze business needs and processes, identify gaps, and assess solution feasibility.
• Bridge business stakeholders and development teams, supporting accurate implementation of requirements.
• Develop a deep understanding of the Edison System, including interactions between software and its subsystems.
• Collaborate with R&D, Quality, Manufacturing, Field Service, Regulatory Affairs, quality assurance, and risk management teams.
• Design test cases and plans, validate software functionality, and identify opportunities for system improvement and integration.

Requirements

• 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.
• Experience creating software requirements documents, use cases, and user stories.
• Expertise in hardware-software integration for medical devices and strong knowledge of software development methodologies.
• Knowledge of medical device regulations and standards, including ISO 13485, ISO 14971, IEC 62304, and design control requirements.
• Strong communication and cross-functional collaboration skills; familiarity with Microsoft DevOps.

Culture & Benefits

• Hybrid work arrangement with approximately 10% travel.
• Health, dental, and vision insurance.
• Life, short-term disability, and long-term disability insurance.
• 401(k) and paid time off.
• U.S. work authorization is required; visa sponsorship is not available.
• Equal opportunity workplace committed to diversity.