Sr. Research Engineer (Biomedical)

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

Position Summary: 

The Sr. Research Engineer will work with the HistoSonics 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:

• Works 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. Manage programs or facets of programs/projects as required.
• Work as a member of the R&D team to plan, set up, carry out, and document scientific experiments related to acoustic, electric, robotic, and software system subcomponents.
• Develop models or computer simulations of human biobehavioral systems to obtain data for measuring or controlling life processes.
• Communicate with suppliers regarding the design or specifications of bioproduction equipment, instrumentation, or materials.
• Develop methodologies for transferring procedures or biological processes from laboratories to commercial-scale manufacturing production.
• Prepare technical reports, data summary documents, or research articles for scientific publication, regulatory submissions, or patent applications.
• 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 HistoSonics 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.
• Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, and communicating to 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 HistoSonics' design control system. 

Qualifications and Skills:

• Bachelor’s degree in biomedical engineering, biotechnology, or physics; advanced degree (Master’s or PhD) preferred in biomedical engineering, biotechnology, or physics.
• 5+ years of industry experience in modeling and simulating biobehavioral systems, advancing material research for product applications, and optimizing acoustic (ultrasound) system design; 3+ years of commercial experience preferred with advanced degree. 
• Experience in complex systems design, engineering and product development (including product support during commercialization).
• Experience driving products through verification and validation, resulting in successful regulatory submissions (globally)
• 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.

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

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