Senior Principal MedTech Product Engineer (Hybrid)

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k)

Paid time off

Job summary

HistoSonics in Plymouth, MN is seeking a Principal Product Development Engineer to lead new product and indication development, translating exploratory research into clinically viable solutions. This hands-on technical leader drives design, prototyping, and evaluation of novel technologies toward first-in-human applications, guiding concepts toward commercialization.

The role requires 8+ years of mechanical design experience and experience with Class 2 energy-based devices, plus travel up to

Qualifications

• Bachelor's degree in biomedical or mechanical engineering.
• 8+ years of mechanical design, development, clinical evaluation, and product transfer to production.
• Experience with the design and development of Class 2, energy-based devices/systems.
• Experience designing and executing pre-clinical studies.
• Proven experience in startup environments supporting early-stage clinical studies.
• Significant experience driving products through verification and validation, resulting in successful regulatory submissions.
• Cross-functional project leadership experience.
• Ability to travel up to 15%.

Responsibilities

• Translate clinical needs into engineering requirements with the cross-functional team.
• Responsible for the timely design, engineering, and development of mechanical systems, subsystems, and related devices. This includes mechanical, electrical, software, and/or system integration related tasks.
• Duties are focused on efficient and effective project engineering, including leading and/or contributing to marketing specifications, engineering specifications, feasibility plan/testing/reports, cost estimation/analysis, detailed mechanical engineering design, design reviews, risk analysis, hazard analysis and FMEA-Design/Process/Use.
• Build and iterate prototypes to validate safety, performance, ergonomics, and mechanical robustness.
• Design and execute bench and pre-clinical studies; analyze data and translate findings into design iterations.
• Establish test methods and acceptance criteria for novel energy delivery mechanisms.
• Conduct various engineering analytical evaluations (e.g. tolerance, material selection, force, stress, thermal, ex vivo/preclinical testing, etc.).
• Participate in engineering for manufacturability and transfer to manufacturing (e.g. assessment of molds/tools required, manufacturing equipment definition/debug/validation, process definition/debug/validation, engineering builds, and product verification testing).
• Ensures design documentation is in accordance with Histosonics’ design control system (or external partner systems) and that all project deliverables are met.

Skills

Mechanical design

Product transfer to production

Pre-clinical studies

Regulatory submissions

Startup experience

Cross-functional leadership

Travel availability

Education

Bachelor's degree in biomedical or mechanical engineering

Job description

HistoSonics in Plymouth, MN is seeking a Principal Product Development Engineer to lead new product and indication development, translating exploratory research into clinically viable solutions. This hands-on technical leader drives design, prototyping, and evaluation of novel technologies toward first-in-human applications, guiding concepts toward commercialization.

The role requires 8+ years of mechanical design experience and experience with Class 2 energy-based devices, plus travel up to