Principal Development Engineer

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.

Location: Plymouth-MN - On-Site 

Summary:

The Principal Development Engineer will work 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 converting laboratory prototypes into cost-effective, scalable and marketable products (organically and with external partners). 

Key Responsibilities:

• Works closely with the Product Owners, Project Management, Development Leadership and the cross-functional team to translate product requirements into system/sub-system 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 engineering for manufacturability and transfer to manufacturing (e.g. assessment of molds/tools required, materials and product verification testing. 
• Ensure that design documentation is in accordance with Histosonics’ design control system (or external partner’s systems) and that all project deliverables are met.
• Required to provide mentorship and work direction to junior engineers.

Qualifications and Skills:

• Bachelor’s Degree in Mechanical Engineering, Electrical Engineering, or related Engineering.
• 10 years of product development experience.
• Experience in complex systems design, engineering and product development (including product support during commercialization).
• Significant experience driving products through verification and validation, resulting in successful regulatory submissions (globally).
• Project leadership (cross-functional) and partnership experience (with successful launches).
• Excellent communication skills and quality management systems experiences.

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.

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