The Automation Engineer is responsible for designing, implementing, validating, and continuously improving manufacturing equipment and processes within a regulated medical device manufacturing environment. This role combines hands-on engineering, automation system development, and project management to support manufacturing efficiency, product quality, and operational excellence. The successful candidate will lead automation projects, develop custom equipment and fixtures, perform process validations, and work closely with cross-functional teams to identify and implement innovative manufacturing solutions. This position requires a strong technical foundation, a proactive problem-solving mindset, and a willingness to spend significant time on the production floor supporting equipment, processes, and continuous improvement initiatives.

• Demonstrate a strong understanding of manufacturing technologies, equipment design, and production processes. Identify equipment and process deficiencies, develop corrective actions, and implement sustainable improvements.
• Lead outsourced automation projects from concept through implementation, including project planning, budget development, timeline management, supplier coordination, and creation of URS, FAT, and SAT documentation.
• Support the introduction of new manufacturing equipment by leading verification, validation, and qualification activities in a regulated environment.
• Design and develop custom fixtures, tooling, and semi-automated manufacturing systems for low-to-medium volume production operations, including mechanical, electrical, and software integration considerations.
• Plan, execute, and document engineering studies, process characterizations, and validation protocols to support manufacturing and quality objectives.
• Analyze manufacturing processes to identify opportunities for improving product quality, process capability, throughput, efficiency, and cost.
• Evaluate medical devices and manufacturing processes against product specifications and applicable ASTM and ISO standards.
• Work directly on the manufacturing floor, spending up to 50% of the time troubleshooting, assembling, testing, and supporting production equipment and processes.
• Create, revise, and maintain production documentation, engineering drawings, work instructions, and change orders in accordance with document control procedures.
• Collaborate with Manufacturing, Quality, R&D, and Operations teams to resolve technical issues and support continuous improvement initiatives.
• Apply knowledge of electrical control systems, sensors, motor controls, and PLC ladder logic to troubleshoot and improve automated equipment. Experience with PLC programming is preferred.
• Support the implementation, validation, and optimization of machine vision systems and inspection technologies. Experience with vision systems is preferred.
• Ensure compliance with company policies, quality system requirements, safety regulations, and documentation standards.
• Foster a collaborative work environment by treating colleagues, suppliers, and customers with professionalism, courtesy, respect, and integrity always

Pay range 80,000-100,000  per year plus bonus. The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. The actual base salary pay will be based on a number of factors such as education, qualifications, certifications, experience, and other job-related factors permitted by law.

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Mechatronics, Automation Engineering, or a related technical discipline
• One to three years related experience.
• Experience with equipment validation, IQ/OQ/PQ protocols, process validation, and change control systems.
• Familiarity with ISO 13485, FDA Quality System Regulations, GMP environments, and risk management methodologies.
• Proficiency with CAD software, electrical design tools, and project management practices.
• Manufacturing experience with a “hands-on” ability and intuitive mechanical knowledge.
• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
• Proficient with 3D CAD (SolidWorks preferred) for fixture and equipment design.
• Familiarity with PLC programming and troubleshooting software (Allen-Bradley, Automation direct, etc.).
• Experience with machine vision software and industrial automation platforms is preferred.
• Working knowledge of statistical analysis and data collection tools (Minitab preferred).
• Experience with ERP, document control, and change management systems in a regulated environment.
• Ability to create and maintain technical drawings, validation documents, and engineering reports.