Manufacturing Automation Engineer- Medical Device

About the Role:

The Senior Manufacturing Automation Engineer is responsible for supporting and optimizing manufacturing equipment, automation systems, and process improvements in a regulated environment. This role focuses on troubleshooting, validation, and ensuring compliance with FDA and cGMP standards.

Responsibilities:

· Support and optimize manufacturing automation systems and equipment

· Troubleshoot PLC-based systems, machine controls, and process issues

· Lead root cause analysis and support CAPA investigations and resolution

· Conduct FMEA and risk assessments for manufacturing processes

· Support validation activities (IQ, OQ, PQ) and design of experiments (DOE)

· Lead equipment upgrades and continuous improvement initiatives

· Analyze equipment performance and implement process improvements

· Develop and maintain SOPs, validation protocols, and technical documentation

· Collaborate with cross-functional teams including Quality, Operations, and Engineering

· Ensure compliance with FDA, cGMP, and ISO 13485 standards

· Mentor junior engineers and support technical training initiatives

Required Qualifications:

· Bachelor’s degree in Engineering (Mechanical, Electrical, or related field)

· 7 years of experience in manufacturing or automation engineering

· Strong experience with PLC systems and machine troubleshooting

· Experience in regulated environments (FDA, cGMP, ISO)

· Hands-on experience with CAPA, root cause analysis, and FMEA

· Experience with validation activities (IQ, OQ, PQ)

· Knowledge of Lean Six Sigma or DMAIC methodologies

Preferred Qualifications (Optional):

· Experience in medical device, pharma, or biotech industries

· Knowledge of ISO 13485 and quality systems

· Experience with statistical analysis tools

· Familiarity with CAD and manufacturing documentation

· Six Sigma certification is a plus

Equal Opportunity Employer:

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check:

Background checks may be conducted in accordance with applicable laws.

Work Authorization:

Applicants must be authorized to work in the United States.