We are seeking a Mechanical Design Engineer with experience in medical device or regulated manufacturing environments to support the design, development, and improvement of mechanical components, assemblies, and manufacturing processes. This role will contribute throughout the full product lifecycle—from concept and design to validation, production support, and continuous improvement—while ensuring compliance with applicable quality and regulatory standards. Key Responsibilities Design and develop mechanical components, subassemblies, and complete systems for medical devices or medical manufacturing equipment. Create and maintain 3D CAD models, drawings, and technical documentation using tools such as SolidWorks, Creo, or equivalent. Apply DFMEA, PFMEA, and risk management principles in accordance with ISO 14971. Support design verification and validation (DV/DV) activities, including tolerance analysis, testing, and documentation. Collaborate cross-functionally with Manufacturing, Quality, Regulatory, R&D, and Supply Chain teams to ensure robust, manufacturable designs. Support manufacturing transfer, process optimization, and root cause analysis of mechanical issues in production. Ensure designs comply with FDA, ISO 13485, and other applicable regulatory requirements. Assist with supplier technical evaluations, component selection, and cost-reduction initiatives. Prepare and maintain design documentation within PLM and document control systems. Participate in continuous improvement initiatives focused on quality, cost, safety, and delivery. Qualifications Bachelor’s degree in Mechanical Engineering or related field. 3-5+ years of experience in mechanical design, preferably within a medical device, pharmaceutical, or regulated manufacturing environment. Proficiency in 3D CAD software (SolidWorks, Creo, AutoCAD, or similar). Strong understanding of GD&T, materials, manufacturing processes (machining, molding, sheet metal, etc.). Experience working under quality systems (ISO 13485, FDA 21 CFR Part 820). Ability to read, create, and interpret engineering drawings and technical specifications. Strong analytical and problem-solving skills. Effective communication skills in English (written and verbal). Preferred Qualifications Experience with medical devices, disposable products, or capital equipment. Knowledge of design controls, change management, and ECO processes. Experience supporting validation protocols (IQ/OQ/PQ). Familiarity with Lean Manufacturing or Six Sigma principles. Bilingual English / Spanish #J-18808-Ljbffr