About

• Description
• We are seeking an accomplished and innovative Senior Automation Mechanical Engineer to provide technical leadership and strategic direction in the development, design, and deployment of advanced automation systems within our medical device manufacturing operations. This role will drive improvements in production efficiency, quality, and scalability through cutting-edge automation solutions. The ideal candidate will have a strong background in automation engineering, system integration, and project leadership. Experience in medical device manufacturing is a plus but not required.

• What You'll Do
• Lead and mentor engineering teams in the design and implementation of automated equipment and systems for manufacturing processes.
• Serve as a technical expert and advisor to cross-functional teams including manufacturing, quality, R&D, and maintenance to identify and prioritize automation opportunities.
• Oversee the development of detailed mechanical designs, including CAD models, drawings, and specifications, ensuring best practices and design for manufacturability.
• Manage complex automation projects from concept through installation, validation, and handoff to operations, ensuring timelines, budgets, and quality standards are met.
• Drive troubleshooting, root cause analysis, and continuous improvement initiatives for existing automation systems.
• Ensure compliance with applicable regulatory standards (e.g., FDA, ISO 13485) during design and implementation, and champion best practices in documentation and validation.
• Lead risk assessments, FMEAs, and design reviews for automation systems.
• Manage relationships with external vendors and integrators, including sourcing components and overseeing outsourced automation projects.
• Prepare and review engineering documentation including design history files, validation protocols, and technical reports.
• Requirements
• What We're Looking For
• Bachelor's degree in Mechanical Engineering or related field.
• 7+ years of experience in mechanical design and automation engineering, with demonstrated leadership in project or team settings.
• Extensive experience with automation systems such as robotics, motion control, sensors, and PLCs.
• Advanced proficiency with CAD software (e.g., SolidWorks, Creo, Inventor).
• In-depth knowledge of manufacturing processes such as machining, assembly, and molding.
• Strong project management, leadership, and communication skills.
• Desired Skills and Attributes
• Expert knowledge of automation technologies including robotics, pneumatics, servo systems, and vision systems.
• Proven ability to design mechanical systems for automated equipment with a focus on manufacturability, reliability, and scalability.
• Advanced understanding of control systems and integration with mechanical components.
• Ability to interpret and create engineering drawings, schematics, and technical documentation.
• Exceptional analytical and problem-solving skills.
• Ability to work independently, lead teams, and collaborate in a multidisciplinary environment.
• Familiarity with medical device regulations is a plus.