Principal Product Engineer

Socket.dev; Plymouth (MN); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health, dental, vision insurance

401(k)

Paid time off

Life insurance

Job summary

HistoSonics, a medtech leader in non-invasive sonic therapy, is seeking a Principal Product Development Engineer in Plymouth, MN (Hybrid). You will lead the translation of breakthrough concepts from ideation to first‑in‑human clinical applications, driving design, prototyping, and evaluation of novel technologies.

You will collaborate with project leads to convert clinical needs into engineering requirements, build prototypes, conduct bench and pre‑clinical studies, and support manufacturability

Qualifications

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

Responsibilities

• Translate clinical needs into engineering requirements with project teams.
• Design, engineer, and develop mechanical systems and related devices.
• Lead design reviews, feasibility testing, cost analysis and risk assessment.
• Build and iterate prototypes to validate safety and performance.
• Perform bench and pre-clinical studies and translate findings into design changes.
• Support manufacturability and transfer to production, including tooling.
• Ensure documentation aligns with design control systems and project deliverables.

Skills

8+ years experience

Mechanical design

Clinical evaluation

Product transfer to production

Startup experience

Regulatory submissions

Cross-functional leadership

Travel up to 15%

Education

Bachelor's in biomedical or mechanical 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: Plymouth, MN (Hybrid)

Position Summary (Why this role matters):

The Principal Product Development Engineer is a hands‑on technical leader responsible for advancing breakthrough concepts from early‑stage ideation through first‑in‑human clinical applications. As the engineering lead for new product and indication development, this role drives the design, prototyping, and evaluation of novel technologies, translating exploratory research into clinically viable solutions. Working at the forefront of innovation, the Principal Product Development Engineer navigates technical uncertainty, solves complex multidisciplinary challenges, and guides emerging concepts through clinical feasibility toward commercialization. This individual plays a critical role in shaping the future of HistoSonics' technology platform by creating and advancing entirely new therapeutic applications and product opportunities.

Key Responsibilities (What you'll do):

• Works closely with Project Leads and the cross‑functional team to translate clinical needs into engineering requirements.
• 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.

Qualifications and Skills:

• 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%.

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.

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