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, MNPosition 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 SolidWorksGenerate and maintain engineering documentation including drawings, BOMs, and revision controlPartner with engineering, manufacturing, sustaining, and suppliers to develop and refine mechanical designsSupport design for manufacturability (DFM) and design for assembly (DFA) initiativesAssist in prototype development, testing, and iterative design improvementsMaintain accurate and up-to-date documentation in compliance with design control requirementsSupport engineering change requests (DCRs) and product lifecycle updatesCollaborate with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing, and Sustaining EngineeringParticipate in design reviews and provide input on feasibility, tolerances, and material selectionMaintain and manage CAD data within the PDM system, ensuring proper file structure, version control, and adherence to company proceduresFollow established PDM workflows for check-in/check-out, revisions, and approvals to ensure data integrity and traceabilitySupport rapid prototyping efforts using 3D printing (FDM and SLA) and CNC machining resourcesMaintain and manage CAD data within the PDM system, ensuring proper file structure, version control, and adherence to company proceduresFollow established PDM workflows for check-in/check-out, revisions, and approvals to ensure data integrity and traceabilityOther duties or projects assignedQualifications & Skills:Associate's degree in Mechanical Design, Drafting, CAD Technology, Engineering Technology, or a related field5+ years of professional experience in mechanical design or drafting, preferably within a medical device or other regulated industryAdvanced proficiency in SolidWorks, including creation of production-ready models and drawingsHands-on experience with prototyping methods such as 3D printing (FDM and SLA) and/or CNC machiningProven ability to generate detailed engineering drawings, including GD&T and tolerance stack-up analysisExperience managing Bills of Materials (BOMs) and working within PDM/PLM systemsWorking knowledge of common manufacturing processes, including machining, injection molding, and sheet metal fabricationUnderstanding of design control processes and documentation requirements in regulated environmentsStrong attention to detail, organization, and documentation accuracyClear communicator with the ability to collaborate effectively in cross-functional teamsBenefits: 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.#LI-Onsite