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HistoSonics, Inc. · 2 months ago

Senior Software Systems Analyst

Plymouth, MN, US

Full-time

Hybrid

Senior Level

$135K/yr - $165K/yr

5+ years exp

HistoSonics is a medical device company focused on advancing the science of histotripsy for non-invasive treatments. The Sr. Software Systems Analyst will act as a liaison between stakeholders and development teams, gathering and documenting software requirements to ensure that the final product meets user needs and business objectives.

Health CareMedicalMedical Device

No H1B

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

Qualification

Medical device developmentSoftware requirement documentationHardware-software integrationSoftware development methodologiesMedical device regulatory frameworksMicrosoft DevOpsCommunication skillsCross-functional teamwork

Required

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