Sr. Mechanical Designer

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

Position Summary (Why this role matters): 

The Senior Mechanical Designer will support HistoSonics Product Development, Manufacturing, and Sustaining teams 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 Mechanical Designer 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):

• Create detailed 3D CAD models, assemblies, and 2D drawings using SolidWorks
• Generate and maintain engineering documentation including drawings, BOMs, and revision control
• Partner with engineering, manufacturing, sustaining, and suppliers to develop and refine mechanical designs
• Support design for manufacturability (DFM) and design for assembly (DFA) initiatives
• Assist in prototype development, testing, and iterative design improvements
• Maintain accurate and up-to-date documentation in compliance with design control requirements
• 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
• Maintain and manage CAD data within the PDM system, ensuring proper file structure, version control, and adherence to company procedures
• Follow established PDM workflows for check-in/check-out, revisions, and approvals to ensure data integrity and traceability
• 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
• Follow established PDM workflows for check-in/check-out, revisions, and approvals to ensure data integrity and traceability
• Other duties or projects assigned

Qualifications & Skills:

• Associate’s degree in Mechanical Design, Drafting, CAD Technology, Engineering Technology, or a related field 
• 5 years of professional experience in mechanical design or drafting, 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 
• Experience managing Bills of Materials (BOMs) and working within PDM/PLM systems 
• Working knowledge of common manufacturing processes, including machining, injection molding, and sheet metal fabrication 
• Understanding of design control processes and documentation requirements in regulated environments 
• 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.

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