MedTech Mechanical Engineer

We are looking for a skilled Mechanical Engineer with strong Medical Device industry experience to support the design, development, and improvement of innovative medical products. The ideal candidate will have hands‑on experience in mechanical design, product development, prototyping, and verification/validation activities within a regulated medical device environment. Job Description Support the design, development, and improvement of innovative medical products within a regulated medical device environment. Required Qualifications & Experience 5+ years of experience as a Mechanical Engineer in the Medical Device / MedTech industry Strong experience designing and developing medical devices, surgical instruments, diagnostic equipment, or electromechanical medical systems Experience working through the full medical device product development lifecycle from concept to production Hands‑on experience with mechanical design, 3D modeling, assemblies, and detailed drawings Proficiency with CAD tools such as SolidWorks, Creo, CATIA, or similar Strong knowledge of GD&T, tolerance stack‑up analysis, and engineering drawings Experience with Design Verification and Validation (DV/V) testing Experience with Design Controls, Risk Management, and documentation for FDA‑regulated products Knowledge of ISO 13485 quality systems and medical device development processes Experience with DFM/DFA, injection molding, plastics, machining, and manufacturing processes Ability to perform root cause analysis, failure analysis, and corrective actions Experience supporting ECO/ECN processes and product changes Key Responsibilities Design, develop, and optimize mechanical components and assemblies for medical devices Create and maintain engineering drawings, specifications, and design documentation Develop prototypes and support design iterations based on testing results Collaborate with cross‑functional teams including R&D, Quality, Regulatory, Manufacturing, and Suppliers Support verification testing, validation activities, and product releases Identify design risks and provide engineering solutions Participate in product improvements, cost reduction initiatives, and sustaining engineering activities Ensure designs meet regulatory, safety, and performance requirements Preferred Experience Experience with Class II / Class III medical devices Experience with FDA submissions, DHF (Design History File), DMR documentation Experience with biocompatible materials and medical‑grade plastics Experience with disposable medical devices, implants, robotics, wearables, or surgical products Education Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field Must‑Have Keywords Medical Device, MedTech, Mechanical Design, Product Development, FDA, ISO 13485, Design Controls, DV/V, SolidWorks, Creo, GD&T, DFM, FMEA, Prototyping, Injection Molding, Sustaining Engineering, Risk Management. #J-18808-Ljbffr