Lead Product Development Engineer – MedTech & Clinical

HISTOSONICS INC; Plymouth (MN); Hybrid; USD 150,000 - 185,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Dental insurance

Vision insurance

Job summary

HistoSonics is seeking a Principal Product Development Engineer in Plymouth, MN to lead hands-on development of breakthrough concepts from ideation to first‑in‑human clinical applications. You will oversee design, prototyping, and evaluation of novel technologies, guiding concepts toward commercialization.

The role requires 8+ years in mechanical design, experience with Class 2 energy-based devices, and a proven startup background supporting early-stage clinical studies.

Qualifications

• 8+ years of mechanical design and product transfer to production.
• Experience with Class 2 energy-based devices/systems.
• Experience designing and executing pre-clinical studies.
• Proven startup experience supporting early-stage clinical studies.
• Driving products through verification and validation leading to regulatory submissions.
• Cross-functional project leadership experience.
• Ability to travel up to 15%.

Responsibilities

• Translate clinical needs into engineering requirements with project leads.
• Design, engineer, and develop mechanical systems, subsystems, and related devices; include integration work.
• Lead and contribute to marketing specs, engineering specs, feasibility plans, testing, cost analysis, and design reviews.
• Build and iterate prototypes to validate safety, performance, ergonomics, and robustness.
• Design and execute bench and pre-clinical studies; analyze data for design iterations.
• Establish test methods and acceptance criteria for energy delivery mechanisms.
• Conduct tolerance, material, force, stress, thermal, and ex vivo/preclinical analyses.
• Support manufacturability and transfer to manufacturing; define tools and processes.
• Ensure design documentation complies with design control systems and project deliverables.

Skills

Cross-functional leadership

Startup experience

Ability to travel

Education

Bachelor's degree in biomedical or mechanical engineering

Job description

HistoSonics is seeking a Principal Product Development Engineer in Plymouth, MN to lead hands-on development of breakthrough concepts from ideation to first‑in‑human clinical applications. You will oversee design, prototyping, and evaluation of novel technologies, guiding concepts toward commercialization.

The role requires 8+ years in mechanical design, experience with Class 2 energy-based devices, and a proven startup background supporting early-stage clinical studies.