Sr. Mechanical Engineer

HistoSonics, Inc.; Ann Arbor (MI); On-site; USD 120,000 - 190,000; Full time

Job summary

HistoSonics, Inc. in Ann Arbor, MI invites a Sr. Mechanical Engineer to join a team turning lab prototypes into scalable medical devices.

You will work with RAD/R&D to translate clinical needs into engineering requirements and drive design and testing across therapy, acoustic, electrical, robotic, and software subsystems. The role emphasizes translational research, preclinical to post-market support, and collaboration for regulatory submissions.

Qualifications

• Bachelor’s degree in engineering (Mechanical, Biomedical, or related).
• 5+ years mechanical engineering experience in medical devices.
• Experience in complex systems design and product development.
• Experience with verification/validation and regulatory submissions.
• Experience in translational research (preclinical/clinical).
• Excellent communication and quality management systems experience.

Responsibilities

• Translate clinical needs into system and engineering requirements with cross-functional teams.
• Plan, set up, run and document experiments on core therapy, acoustic, electric, robotic, and software subsystems.
• Develop and execute preclinical models to support proof of concept and regulatory submissions.
• Contribute to design output documentation and technical reports for publications or filings.
• Collaborate on IP matters including patent disclosures and prosecution support.
• Apply statistical models to analyze in vivo and ex vivo testing results.
• Maintain compliance with the Quality Management System and design controls.

Skills

Mechanical Engineering

Medical Devices

System Design

Regulatory Submissions

Translational Research

Education

Bachelors in Engineering

Job description

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

Position Summary (Why This Role Matters)

The Sr. Mechanical 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 (What You’ll Do)

• 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. Manage programs or facets of programs/projects as required.
  • This may include new high priority Advanced Systems feature and capability development including but not limited to development of new therapy transducer design improvements and refinements, 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 with 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.

Qualifications And Skills

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

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.