Sr. Systems Engineer

Location: Ann Arbor

About the Role

The Sr. Systems 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).

Responsibilities

• Work 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, including new high-priority Advanced Systems feature and capability development (e.g., new/refined system configurations). Translate designs into clinically relevant product configurations and prototypes for bench, ex vivo, and preclinical studies to inform first-in-human design decisions.
• Plan, set up, carry out, and document scientific experiments related to core therapy, acoustic, electric, robotic, and software system subcomponents as a member of the RAD and R&D team.
• Design or develop medical diagnostic or clinical instrumentation, equipment, or procedures using 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 biological systems in humans and animals.
• Develop 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 intellectual property matters, including new patent disclosures, applications, and support during prosecution.
• Contribute to risk analysis and decision-making processes related to features, specifications, and characteristics of 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 openly and objectively.
• Perform responsibilities in compliance with the Company’s Quality Management System.
• Ensure design documentation aligns with HistoSonics’ RAD research practices and the company’s design control system.

Requirements

• Master’s degree in engineering (Biomedical, Mechanical, Electrical, or similar) and 2+ years of related industrial work experience in a relevant space, or Bachelor’s degree plus 5+ years of related industrial work experience.
• Experience with medical devices required; ultrasound-based medical devices preferred.
• Experience in complex systems design, engineering, and product development.
• Experience driving products through verification and validation, resulting in successful regulatory submissions (globally) desired.
• Experience in translational research (preclinical and/or human clinical).
• Excellent communication skills and quality management systems experience.

Benefits

• Comprehensive benefits package for full-time employees, including health, dental, and vision insurance.
• Life, short-term, and long-term disability insurance.
• 401(k) retirement plan.
• Paid time off.

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