Principal Product Engineer

HISTOSONICS•Plymouth, MN

5d•Hybrid

About The Position

HistoSonics 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, HistoSonics 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. The Principal Product Development Engineer is a hands-on technical leader responsible for advancing breakthrough concepts from early-stage ideation through first-in-human clinical applications. As the engineering lead for new product and indication development, this role drives the design, prototyping, and evaluation of novel technologies, translating exploratory research into clinically viable solutions. Working at the forefront of innovation, the Principal Product Development Engineer navigates technical uncertainty, solves complex multidisciplinary challenges, and guides emerging concepts through clinical feasibility toward commercialization. This individual plays a critical role in shaping the future of HistoSonics' technology platform by creating and advancing entirely new therapeutic applications and product opportunities.

Requirements

Bachelor's degree in biomedical or mechanical engineering.
8+ years of mechanical design, development, clinical evaluation, and product transfer to production.
Experience with the design and development of Class 2, energy-based devices/systems.
Experience designing and executing pre-clinical studies.
Proven experience in startup environments supporting early-stage clinical studies.
Significant experience driving products through verification and validation, resulting in successful regulatory submissions.
Cross-functional project leadership experience.
Ability to travel up to 15%.

Responsibilities

Works closely with Project Leads and the cross-functional team to translate clinical needs into engineering requirements.
Responsible for the timely design, engineering, and development of mechanical systems, subsystems, and related devices. This includes mechanical, electrical, software, and/or system integration related tasks.
Duties are focused on efficient and effective project engineering, including leading and/or contributing to marketing specifications, engineering specifications, feasibility plan/testing/reports, cost estimation/analysis, detailed mechanical engineering design, design reviews, risk analysis, hazard analysis and FMEA-Design/Process/Use.
Build and iterate prototypes to validate safety, performance, ergonomics, and mechanical robustness.
Design and execute bench and pre-clinical studies; analyze data and translate findings into design iterations.
Establish test methods and acceptance criteria for novel energy delivery mechanisms.
Conduct various engineering analytical evaluations (e.g. tolerance, material selection, force, stress, thermal, ex vivo/preclinical testing, etc.).
Participate in engineering for manufacturability and transfer to manufacturing (e.g. assessment of molds/tools required, manufacturing equipment definition/debug/validation, process definition/debug/validation, engineering builds, and product verification testing).
Ensures design documentation is in accordance with Histosonics’ design control system (or external partner systems) and that all project deliverables are met.