HISTOSONICS INC

Compensation

Full Description

HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients. Location: Plymouth-MN (Hybrid), or Ann Arbor-MI (Hybrid) Position Summary: The Software Project Manager, Connectivity proactively leads the planning, coordination, and execution of medical device software development projects for the Edison system. This role is responsible for managing software projects from concept through commercialization, ensuring cross-functional alignment, regulatory compliance, and timely delivery. The Software Project Manager works with the Software Leadership team to identify resources, manage dependencies, meet schedule milestones, and adjust to complex project issues. Key Responsibilities * Lead the execution of software projects, including feasibility, prototyping, development, documentation, verification and validation. * Facilitate effective collaboration across program leaders, project managers, software development, test, and risk management resources. * Engages with cross-functional teams to communicate and manage dependencies * Monitor progress, oversee software configuration management, manage and produce documentation deliverables and escalate risks and impediments appropriately. * Serve as a central point of contact for internal and external stakeholders, providing regular software project updates and status reports. Qualifications * Bachelor’s degree in computer engineering, computer science, software engineering, or a closely related technical field. * Minimum of 5 years of software development experience within medical devices or other highly regulated industries. * At least 3 years of demonstrated success managing end-to-end software development lifecycle projects, including cloud-hosted SaaS or connected applications, using Agile/Scrum methodologies and tools such as Jira or Azure DevOps. * Experience collaborating within matrixed organizations and cross-site or global teams, partnering with software architects, data scientists, engineers, quality assurance, and regulatory stakeholders. * Exposure to manufacturing transfer, service deployment, and post-market surveillance activities is preferred.  * Strong understanding of cloud computing platforms, technologies, and best practices across major providers (AWS, Azure, or Google Cloud). * Familiarity with DevOps principles and CI/CD pipelines for cloud-based application deployment. * Working knowledge of networking, security protocols, and database management concepts in cloud environments. * Experience working with FDA medical software guidance, IEC 62304, HIPAA, GDPR, and other applicable regulations. * Understanding of phase-gate or milestone-driven product development, with the ability to ensure project documentation and processes meet regulatory compliance requirements. * Willingness to travel domestically up to 10%.   Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.