Associate Test 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: Ann Arbor, MI - Onsite

Travel: Up to 20%

Position Summary (Why this role matters):

The Associate Test Engineer role will work with the HistoSonics team in the design, engineering, development and testing of the Company’s globally regulated clinical systems and will provide support to the Research and Advanced Development (RAD) team. They will play an active role in converting laboratory prototypes into cost-effective, scalable and marketable products (organically and with external partners). This would include involvement with thermal testing, test development and documentation, prototype builds, troubleshooting, verification, electrical soldering, and general lab work. The key responsibilities of the associate engineer range from research support and feasibility analysis to the hand off to commercialization while closely adhering to HistoSonics’ quality system and design controls. 

Key Responsibilities (What you’ll do):

• Assist in the fabrication of all phantom types utilized in RAD therapy development workflows.
• Conduct benchtop testing of therapy transducers, including thermal characterization and treatment of phantoms/ex-vivo tissues to assess the effectiveness of novel therapy configurations.
• Data analysis of benchtop results. 
• Document test procedures and methods for hand off to development and commercialization.
• Assist with building of prototype products including mechanical and electrical sub systems.
• Debug and resolve test failures with changes to the design.
• Run experiments in the lab as required.
• Assist with animal trials.
• Organize and maintain RAD wet lab spaces.
• Work closely with the R&D management team (Head of Research and Product Development) and the cross-functional team to translate clinical needs into engineering requirements.
• Conduct/support various engineering analytical evaluations related to the Company’s product (e.g. thermal, ex vivo/preclinical testing, etc.).
• Ensure that design documentation is in accordance with Histosonics’ design control system (or external partner’s systems) and that all project deliverables are met.

Qualifications and Skills:

• Bachelor’s degree in Biomedical, Mechanical or Materials engineering. 
• 0-2 years of medical device, related industrial, academic research, or co-op experience preferred. Candidates with parallel hands-on experience (e.g., ultrasound research lab, biomedical wet lab, materials/test lab, or medical device R&D internship) are welcome. 
• Experience with mechanical and electrical prototyping, troubleshooting, and test.
• Experience in complex systems design and engineering principles preferred. 
• Experience driving products through verification and validation preferred. 
• Excellent communication skills and quality management systems experiences.
• Strong analytical, critical thinking, and problem-solving skills with an attention to detail and organizational goals.
• Excellent written and verbal communication skills; comfortable with participating in high-level technological discussions; ability to discuss complex technology in clear, discernible terms with less technically knowledgeable parties.
• Experience with data processing software (e.g. MATLAB and Python) is a plus.
• Must be willing to travel up to 20%.

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.

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