HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients.
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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Skills Required
- Bachelor's degree in biomedical engineering, biotechnology, or physics
- Advanced degree (Master's or PhD) in biomedical engineering, biotechnology, or physics
- 5+ years industry experience in modeling and simulating biobehavioral systems and optimizing acoustic (ultrasound) system design
- 3+ years commercial experience (preferred when holding an advanced degree)
- Experience in complex systems design, engineering, product development, and commercialization support
- Experience driving products through verification and validation and supporting regulatory submissions globally
- Experience with quality management systems and design control documentation
- Experience creating, developing, or executing preclinical models and participating in preclinical/clinical research
- Ability to develop methodologies for transferring lab procedures to commercial-scale manufacturing and communicate with suppliers
- Excellent written and verbal communication skills
- Authorization to work in the U.S. without visa sponsorship
What We Do
HistoSonics is a growth phase company developing a non-invasive sonic beam therapy platform and procedure using the science of histotripsy. Histotripsy utilizes the pressure created by focused sound energy to liquefy and destroy targeted tissue, including diseased tissue and tumors, at sub-cellular levels. The company’s new platform delivers personalized, tissue specific treatments with precision and control, and without the undesirable side effects of many of today’s interventional and surgical modalities. HistoSonics is led by a team of experienced domain experts and industry leaders with offices in Ann Arbor, MI, Madison, WI, and Minneapolis, MN.
