Senior Software Systems Analyst
About The Position
The Senior Software Systems Analyst acts as a liaison between stakeholders and development teams, gathering, analyzing, and documenting software requirements. The role translates business needs into clear technical specifications so the resulting software meets user needs and business objectives. The analyst develops a deep understanding of the HistoSonics system and how Edison software interacts with its subsystems, while ensuring development aligns with the product vision and company goals. The role works across R&D, Quality, Manufacturing, Field Service, and Regulatory Affairs, supporting requirements, testing, risk management, and quality assurance activities. This is a hybrid position based in Plymouth, Minnesota, or Ann Arbor, Michigan, with approximately 10% travel. Candidates must be authorized to work in the United States; the employer will not sponsor visas for this position.
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 team members.
- 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 in clear documents 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 and identify opportunities for improvement, optimization, and integration of new features.
- Collaborate with R&D, Quality, Manufacturing, Field Service, and Regulatory Affairs.
- Collaborate with quality assurance teams to design test cases, scenarios, and 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 suggest process improvements and innovative solutions.
- Maintain awareness of relevant medical device standards, including IEC 62304 and ISO 14971, and design control requirements.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short-term and long-term disability insurance
- 401(k)
- Paid time off
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
