Senior MedTech Systems Engineer — Translational R&D

HistoSonics, Inc.; Ann Arbor (MI); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Job summary

HistoSonics is seeking a Sr. Systems Engineer in Ann Arbor to advance the Edison System. You will convert lab prototypes into cost-effective, scalable products and work with RAD/R&D to define system configurations for bench, ex vivo, and preclinical studies.

Key responsibilities include designing experiments, developing test procedures, and ensuring documentation supports regulatory submissions. A strong background in medical devices and translational research is essential.

Qualifications

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

Responsibilities

• Translate clinical needs into core therapy, system and engineering requirements with RAD/R&D teams.
• Plan and execute scientific experiments related to core therapy, acoustic, electric, robotic, and software subsystems.
• Develop preclinical models supporting proof of concept and regulatory submissions.
• Participate in preclinical or clinical studies and document results.
• Develop design outputs and reports for regulatory submissions and patent applications.
• Document and manage related IP matters and risk analyses.
• Apply statistical models to analyze in vivo/ex vivo testing results.

Skills

Complex systems design

Verification and validation

Strong communication

Quality management systems

Education

Master’s in Biomedical/Mechanical/Electrical Engineering

Bachelor’s with 5+ years experience

Tools

Statistical modeling software

Job description

HistoSonics is seeking a Sr. Systems Engineer in Ann Arbor to advance the Edison System. You will convert lab prototypes into cost-effective, scalable products and work with RAD/R&D to define system configurations for bench, ex vivo, and preclinical studies.

Key responsibilities include designing experiments, developing test procedures, and ensuring documentation supports regulatory submissions. A strong background in medical devices and translational research is essential.