Principal Engineer, New Indications

HISTOSONICS INC • Plymouth, MN

37d • 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.

Position Summary:

The Principal Engineer, New Indications, will be the Technical Lead with the HistoSonics team in the design, engineering, development and testing of the Company’s globally regulated clinical systems and serve as the engineering lead in the design and build of the system and/or sub-systems related to the Company’s products, as well as launch support. They will play an active role in translating new concepts from laboratory prototypes into clinical evaluation and eventual commercialization.

Requirements

• Bachelor’s degree in engineering.
• 8+ years of design, development, clinical evaluation and/or product transfer to production of medical devices; 5+ years with master’s degree.
• Experience in complex systems design, engineering and product development (including product support during commercialization). Have a strong background in systems engineering.
• Experience with early-stage clinical studies and clinical evaluation of new concepts. Have background and experience supporting first in man or human feasibility clinical studies.
• Have background an experience in a start-up environment.
• Project leadership (cross-functional) and partnership experience (with successful launches).
• Significant experience driving products through verification and validation, resulting in successful regulatory submissions (global experience preferred).
• Excellent communication skills and quality management systems experience.
• Must be willing and able to travel up to approximately 25%.

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 the Company’s product-related mechanical systems, subsystems and related devices. This includes electrical, mechanical, 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.
• Conduct various engineering analytical evaluations related to the Company’s product (e.g. tolerance, material selection, force, stress, thermal, ex vivo/preclinical testing, etc.).
• Participate in the 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 that design documentation is in accordance with Histosonics’ design control system (or external partner’s systems) and that all project deliverables are met.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 101-250 employees