3D Modeling, 3D Printing, Bill of Materials (BOM), CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), CNC (Computerized Numerical Control) Systems, Clinical Information Systems, Communication Skills, Cross-Functional, Data Management, Design Verification, Detail Oriented, Disease, Documentation, Drug Development, Engineering, Engineering Change Order, Engineering Drawing, FDA (Food and Drug Administration), FDM (Frequency Division Multiplexing), Human Health, Manufacturing, Manufacturing Requirements, Mechanical Assembly, Mechanical Design, Mechanical Engineering, Medical Equipment, Product Data Management (PDM), Product Development, Product Documentation, Product Lifecycle, Product Support, Prototyping, Rapid Prototyping, Reimbursement, Requirements Management, Research & Development (R&D), Risk Analysis, Robotics, Service Level Agreement (SLA), SolidWorks, Source Code/Configuration Management (SCM), Team Player, Technical Support, Test Plan/Schedule, Testing, Validation Documentation, Willing to Travel, Women's Health
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
Travel: 10%
Position Summary (Why this role matters):
The Mechanical Development Engineer will support HistoSonics Product Development in the design, development, and documentation of mechanical components and assemblies for the Company's globally regulated clinical systems. This role is responsible for creating detailed CAD models, engineering drawings, and design documentation, while collaborating closely with engineers and cross-functional teams to support product development and manufacturing efforts.
The Senior Development Engineer will play a key role in translating engineering concepts and prototypes into robust, manufacturable designs suitable for production in a regulated medical device environment.
Key Responsibilities (What you'll do):
- Generate and maintain engineering documentation including drawings, BOMs, and revision control
- Partner with engineering, manufacturing, sustaining, and suppliers to develop and refine mechanical designs
- Develop product and user requirements, test procedures, and design output and verification and validation documentation for the product.
- Contributes to risk analysis and decision-making processes related to features, specifications, and characteristics of our products.
- Create detailed 3D CAD models, assemblies, and 2D drawings using SolidWorks
- Assist in prototype development, testing, and iterative design improvements
- Support engineering change requests (DCRs) and product lifecycle updates
- Collaborate with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing, and Sustaining Engineering
- Participate in design reviews and provide input on feasibility, tolerances, and material selection
- Support rapid prototyping efforts using 3D printing (FDM and SLA) and CNC machining resources
- Maintain and manage CAD data within the PDM system, ensuring proper file structure, version control, and adherence to company procedures
Qualifications & Skills:
- Bachelor's degree in Mechanical, Robotics or similar Engineering field
- 5+ years of mechanical engineering experience, preferably within a medical device or other regulated industry
- Advanced proficiency in SolidWorks, including creation of production-ready models and drawings
- Hands-on experience with prototyping methods such as 3D printing (FDM and SLA) and/or CNC machining
- Proven ability to generate detailed engineering drawings, including GD&T and tolerance stack-up analysis
- Strong attention to detail, organization, and documentation accuracy
- Clear communicator with the ability to collaborate effectively in cross-functional teams
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.