Senior Software Systems Analyst
HISTOSONICS INC
Summary
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.
Job description
Position Summary
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.
Key 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.
Qualifications and Skills
- 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.
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
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- 401(k)
- Paid Time Off
Company overview
HistoSonics Inc. is a venture-backed medical device company pioneering non-invasive sonic beam therapy using the science of histotripsy. Founded in 2009 and headquartered in Plymouth, Minnesota with additional offices in Ann Arbor, Michigan, the company has grown from 40 employees to over 200 professionals. HistoSonics' proprietary Edison System utilizes focused sound energy to create pressure that liquefies and destroys targeted tissue at sub-cellular levels, offering a revolutionary approach to treating tumors and diseased tissue without incisions, radiation, or heat. The company's technology represents a new category of non-invasive, image-guided therapy that provides personalized, tissue-specific treatments with precision and control while minimizing undesirable side effects. Currently, the Edison System has been used to treat over 1,000 patients for liver tumors at nearly 50 active centers across the United States, United Arab Emirates, and Hong Kong. HistoSonics recently secured $250 million in growth financing from prominent investors including Thiel Bio, Founders Fund, and Bezos Expeditions, positioning the company to expand into new clinical applications and global markets while advancing its mission to deliver innovative treatment options to patients worldwide.