Sr. Systems Analyst - Medical Device

Salary Range: $135,000-$160,000 annually + Equity

Travel Expectation: ~25% travel to other Midwest sites, typically 1× per month for 2-3+ days.

The Senior Software Systems Analyst serves as a critical link between stakeholders and development teams—gathering, analyzing, and documenting requirements to translate business needs into clear, actionable technical specifications. This role ensures alignment between user expectations, engineering execution, and overall product objectives.

• Develop detailed specifications, user stories, functional requirements, and use cases for both technical and non‑technical audiences.
• Analyze business processes, identify gaps, and assess feasibility of potential solutions.
• Act as liaison between business stakeholders and software development teams to ensure shared understanding of requirements.
• Support developers by clarifying requirements and ensuring accurate implementation.
• Build deep knowledge of the company's integrated medical device system, including system‑level interactions and software-hardware dependencies.
• Ensure software development activities align with product vision and organizational goals.
• Conduct analysis of existing software systems to identify opportunities for optimization and feature enhancement.
• Collaborate with cross‑functional teams including R&D, Quality, Manufacturing, Field Service, and Regulatory Affairs.
• Partner with quality assurance to create test cases, scenarios, and validation plans derived from requirements.
• Contribute to risk management activities by identifying, documenting, and tracing risks to requirements and implementation.
• Review and validate software functionality to ensure compliance with defined requirements.
• Stay current on industry best practices and emerging technologies to recommend process improvements.
• Maintain awareness of relevant medical device standards (e.g., IEC 62304, ISO 14971) and design control requirements.

• Bachelor's degree in Computer Science, Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field.
• 5+ years of experience in a regulated industry or medical device development.
• Strong written and verbal communication skills, including the ability to translate technical details for non‑technical audiences.
• Proficiency in creating structured software requirement documents, use cases, and user stories.
• Demonstrated ability to work effectively with cross‑functional teams.
• Expertise in hardware-software integration for medical devices.
• Strong understanding of software development methodologies.
• Familiarity with software development tools (e.g., Microsoft Dev Ops).
• Solid knowledge of medical device regulatory frameworks, including ISO 13485 and ISO 14971.

• Requirements Documentation
• Use Cases
• Risk Analysis
• FMEA
• Software Development

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

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