Sr. Mechanical Engineer

Sr. Mechanical 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.

Location:

Ann Arbor, MI

Position Summary (Why this role matters):

The Sr. Mechanical 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).

Key Responsibilities (What you'll do):

• 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.
• 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.
• Create, develop and/or execute relevant preclinical models supporting proof of concept, premarket and/or post-market evidence.
• Participate in preclinical and/or clinical research studies.
• Participate in developing requirements, test procedures, and design output documentation for Histo Sonics products.
• 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.
• 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.

Qualifications and Skills:

• Bachelor's degree in engineering (Mechanical, Biomedical, or related).
• 5+ years of mechanical engineering experience in medical device; ultrasound based medical devices preferred.
• Experience in complex systems design, engineering and product development required.
• Experience driving products through verification and validation, resulting in successful regulatory submissions (globally) desired.
• Experience in translational research (preclinical and/or human clinical) required.
• Excellent communication skills and quality management systems experience.

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.

U.S. Work Authorization & Sponsorship:
Employer will not sponsor visas for position.