Senior Advanced Systems Engineer

HISTOSONICS INC • Ann Arbor, MI

6h • Onsite

About The Position

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.

THE SR. ADVANCED SYSTEMS ENGINEER WILL WORK WITH THE HISTOSONICS TEAM IN RESEARCH, DESIGN, ENGINEERING, DEVELOPMENT AND TESTING IN SUPPORT OF THE COMPANY’S TECHNOLOGY AND PRODUCT DEVELOPMENT PLANS.  THEY WILL PLAY AN ACTIVE ROLE IN CREATING, RESEARCHING, DEFINING, AND ENABLING THE EARLY DEVELOPMENT OF RESEARCH LABORATORY PROTOTYPES INTO COST-EFFECTIVE, SCALABLE AND MARKETABLE PRODUCTS (ORGANICALLY AND WITH EXTERNAL PARTNERS/COLLABORATORS).  THIS ROLE WILL SPECIFICALLY SUPPORT ADVANCED SYSTEMS PROGRAMS INCLUDING BUT NOT LIMITED TO THE DEVELOPMENT OF NEW SYSTEM CONFIGURATIONS FOR ADDITIONAL APPLICATION/INDICATION/ANATOMICAL SPECIFIC SOLUTIONS, AS WELL AS IMPROVEMENTS/REFINEMENTS TO THE PRIMARY SYSTEM HARDWARE AND SOFTWARE, AND DEVELOPMENT OF RECEIVE BASED ALGORITHMS TO AUGMENT THE CURRENT AND FUTURE SYSTEM CONFIGURATIONS.

Requirements

• PhD degree in engineering (Biomedical, Mechanical, or Electrical) or Physics or Master’s degree plus 3 to 5 years related industrial work experience in relevant space required
• Academic research or industry experience in the development or use of focused ultrasound (histotripsy, HIFU, and or other therapeutic ultrasound) systems required
• Demonstrated knowledge of medical ultrasound and its use in medical device development including in research and commercial environments
• Experience in complex systems design, engineering and product development required
• Experience in translational research (preclinical and/or human clinical) required
• Excellent communication skills and quality management systems experiences

Nice To Haves

• Experience driving products through verification and validation, resulting in successful regulatory submissions (globally) desired

Responsibilities

• 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. This may include new high priority Advanced Systems feature and capability development including but not limited to development of new system configurations, system improvements/refinements, and therapy receive based algorithms, as well as translation of those designs into clinically relevant product configurations and prototypes for bench, ex vivo, and preclinical studies informing first in human design decisions/configurations, and/or other parts of the early research/development process
• 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.
• Design or develop medical diagnostic or clinical instrumentation, equipment, or procedures, using the principles of engineering and biobehavioral sciences.
• Adapt or design computer hardware or software for medical science uses
• Create, develop and/or execute relevant preclinical models supporting proof of concept, premarket and/or post-market evidence.
• Evaluate the safety, efficiency, and effectiveness of biomedical equipment
• Participate in preclinical and/or clinical research studies.
• Conduct research, along with life scientists, chemists, and medical scientists, on the engineering aspects of the biological systems of humans and animals.
• Participate in developing requirements, test procedures, and design output documentation for HistoSonics products.
• Prepare technical reports, data summary documents, or research articles for scientific publication, regulatory submissions, or patent applications.
• 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.
• Develop statistical models or simulations, using statistical or modeling software
• Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, 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' RAD research practices as well as the company’s design control system.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree