Senior Manufacturing Automation Engineer-Medical Device

Job Summary:

We are seeking an experienced Senior Manufacturing Automation Engineer to support advanced manufacturing operations within a highly regulated production environment. This role is responsible for automation equipment improvements, process optimization, manufacturing reliability, validation execution, and engineering-driven continuous improvement initiatives. The ideal candidate will combine strong automation troubleshooting expertise with project leadership, quality compliance, and hands-on manufacturing engineering knowledge.

Key Responsibilities:

• Lead specification, acquisition, installation, and implementation of manufacturing automation equipment and related systems

• Drive automation upgrade projects focused on safety enhancement, equipment obsolescence mitigation, and process efficiency improvement

• Troubleshoot machine logic, electromechanical systems, controls architecture, and manufacturing process failures to drive timely resolution

• Lead root cause investigations for manufacturing deviations, downtime events, and process failures using structured problem-solving methodologies

• Perform risk assessments, failure modes and effects analysis, and equipment suitability evaluations across manufacturing lines

• Design and execute validation studies, engineering experiments, data analysis, and process verification activities for equipment and process changes

• Identify and implement new methods, materials, and process enhancements to improve throughput, compliance, and product quality

• Develop and revise manufacturing documentation including standard operating procedures, validation protocols, technical specifications, and safety instructions

• Lead cross functional engineering projects and coordinate activities with maintenance, quality, operations, and project management teams

• Support CAPA investigations, quality incident resolution, and corrective action implementation within a regulated manufacturing environment

• Mentor junior engineers and technical staff while providing process expertise, training, and technical guidance

• Ensure all engineering activities comply with applicable quality standards, safety requirements, and regulated manufacturing procedures

Required Qualifications:

• Bachelor’s degree in Engineering or equivalent technical discipline

• Minimum seven years of engineering experience within a manufacturing environment

• Strong hands-on experience with automation equipment, electromechanical systems, PLC logic, and process controls troubleshooting

• Experience leading manufacturing equipment upgrades, validation projects, and continuous improvement initiatives

• Working knowledge of Lean Six Sigma, DMAIC, or other structured root cause analysis methodologies

• Experience with change management, engineering documentation control, and technical project execution

• Strong technical writing, data analysis, and cross functional communication skills

• Proficiency with Microsoft Office applications including Excel, PowerPoint, and reporting tools

Preferred Qualifications:

• Experience working within FDA, ISO, cGMP, or other regulated manufacturing environments

• Knowledge of ISO 13485 quality systems and compliant engineering practices

• Experience with CAPA investigations, risk management, and validation protocol development

• Familiarity with CAD systems, fabrication principles, and manufacturing design reviews

• Experience using statistical analysis tools and manufacturing performance metrics

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $40/hr to $50/hr