Sr. Systems Engineer

Histo Sonics is a commercial-stage medtech company advancing the Edison® System, a novel non‑invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non‑invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, Histo Sonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.

We offer an exciting work culture where cutting‑edge science meets real‑world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.

Location: Ann Arbor

The Sr. Systems Engineer will work with the Histo Sonics team in the research, design, engineering, development and testing in support of the Company’s technology and product development. They will play an active role in converting laboratory prototypes into cost‑effective, scalable and marketable products (organically and with external partners/collaborators).

• Works closely with the Research and Advanced Development (RAD) and R&D management team (Head of Research and Product Development) and the cross‑functional team to translate clinical needs into core therapy, system and engineering requirements. Manage programs or facets of programs/projects as required.
  • This may include new high priority Advanced Systems feature and capability development including but not limited to development of new/refined system configurations, as well as translation of those designs into clinically relevant product configurations and prototypes for bench, ex vivo, and preclinical studies informing first in human design decisions/configurations, and/or other parts of the early research/development process
• Work as a member of the RAD and R&D team to plan, set up, carry out, and document scientific experiments related to core therapy, acoustic, electric, robotic, and software system subcomponents.
  • Design or develop medical diagnostic or clinical instrumentation, equipment, or procedures, using the principles of engineering and biobehavioral sciences.
  • Adapt or design computer hardware or software for medical science uses
• Create, develop and/or execute relevant preclinical models supporting proof of concept, premarket and/or post‑market evidence.
  • Evaluate the safety, efficiency, and effectiveness of biomedical equipment
• Participate in preclinical and/or clinical research studies.
  • Conduct research, along with life scientists, chemists, and medical scientists, on the engineering aspects of the biological systems of humans and animals.
• Participate in developing requirements, test procedures, and design output documentation for Histo Sonics products.
  • Prepare technical reports, data summary documents, or research articles for scientific publication, regulatory submissions, or patent applications.
• Document, manage and collaborate on related intellectual property matters including new patent disclosures, applications and support during prosecution process.
• Contribute to risk analysis and decision‑making processes related to features, specifications, and characteristics of our products.
• Use statistical models and methods to analyze and present in vivo and ex vivo testing results.
  • Develop statistical models or simulations, using statistical or modeling software
• Maintain a positive, results‑oriented work environment, building partnerships and modeling teamwork, communicating with team members in an open, balanced and objective manner.
• Perform applicable responsibilities in compliance with the Company's Quality Management System.
• Ensure that design documentation is in accordance with Histo Sonics' RAD research practices as well as the company’s design control system.

• Master’s degree in…