We are seeking a highly skilled and innovative Senior Design Engineer to lead the design, development, and implementation of advanced automated equipment for medical device manufacturing. This role is responsible for creating custom automation solutions that improve productivity, quality, and process reliability while ensuring compliance with medical device regulatory requirements. The adecuado candidate will possess extensive experience in mechanical design, automation systems, machine development, and Solid Works. This position requires close collaboration with Automation, Manufacturing, Quality, Validation, and Operations teams to design and deliver high-performance automated manufacturing equipment from concept through production deployment. Key Responsibilities Lead the mechanical design and development of custom automated machinery and equipment for medical device manufacturing processes. Create detailed 3 D models, assemblies, component drawings, and engineering documentation using Solid Works. Develop innovative automation solutions including assembly equipment, test systems, robotic work cells, material handling systems, and vision-guided applications. Collaborate with Automation, Controls, Manufacturing, and Quality Engineering teams to ensure successful machine integration and functionality. Perform design calculations, tolerance stack-up analyses, risk assessments, and feasibility studies. Apply Design for Manufacturing (DFM), Design for Assembly (DFA), and ergonomic principles throughout the equipment development process. Generate machine specifications, Bills of Materials (BOMs), assembly instructions, and technical documentation. Support prototype builds, machine debugging, design verification, installation, commissioning,



and validation activities. Participate in equipment FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing). Qualifications Bachelor's degree in Mechanical Engineering, Mechatronics Engineering, Automation Engineering, or related technical discipline. Minimum of 7 years of experience in mechanical design and development of automated manufacturing equipment. Advanced proficiency in Solid Works, including: 3 D Part Modeling Complex Assemblies Weldments Sheet Metal Design GD&T; Motion Studies Drawing Creation and Documentation Experience designing automation equipment for regulated manufacturing environments, preferably within the medical device industry. Strong understanding of mechanical systems, pneumatics, servo systems, robotics, linear motion technologies, and machine design principles. Experience working with industrial automation systems including PLC-controlled equipment and robotic integration. Knowledge of machine safety standards and risk assessment methodologies. Strong troubleshooting, analytical, and problem-solving skills. Experience managing multiple projects and engineering deliverables simultaneously. Excellent communication and technical documentation skills. Advanced English proficiency (written and verbal). Preferred Skills Experience in medical device manufacturing and regulated environments. Knowledge of FDA, ISO 13485, and GMP requirements. Experience with robotics platforms such as Epson, FANUC, ABB, or Universal Robots. Experience integrating vision systems such as Cognex or Keyence. Knowledge of pneumatic and electromechanical automation systems. Familiarity with Lean Manufacturing and Six Sigma methodologies. Experience supporting New Product Introduction (NPI) and manufacturing transfers. #J-18808-Ljbffr

📌 Sr mechanical design engineer (automation) (Centro-Norte)
🏢 Merit Medical
📍 Centro-Norte