Manufacturing Engineer

The Manufacturing Engineer supports manufacturing operations by assisting with process validation, documentation, data analysis, and continuous improvement initiatives. Working closely with senior engineers and cross-functional teams, this role contributes to the development, optimization, and qualification of manufacturing processes in a regulated environment.

• →Support equipment and process validation activities (IQ/OQ/PQ), including protocol development, execution, and reporting.
• →Assist in developing inspection methods, control plans, sampling plans, and manufacturing quality controls.
• →Prepare and maintain manufacturing documentation, including work instructions, equipment procedures, preventive maintenance, calibration, and process documentation.
• →Participate in manufacturing projects from planning through implementation, collaborating with Manufacturing, Quality, R&D, Regulatory, and Supply Chain teams.
• →Apply engineering tools such as DOE, FMEA/PFMEA, SPC, risk analysis, and root cause investigations to improve manufacturing processes.
• →Support Lean Manufacturing and continuous improvement initiatives focused on quality, productivity, yield, cycle time, and cost reduction.
• →Assist with manufacturing technologies including automation, tooling, fixtures, vision systems, laser welding, heat bonding, injection molding, equipment qualification, and test methods.
• →Support CAPA investigations, change controls, nonconformance investigations, process transfers, and product scale-up activities.

• Bachelor's degree in mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or a related engineering discipline.
• One to three years of experience in Manufacturing Engineering, Process Engineering, Quality Engineering, Validation, or a related role within a regulated manufacturing environment is preferred.
• Working knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, ISO 13485, and Good Documentation Practices is preferred.
• Familiarity with process validation, equipment qualification, automation, manufacturing systems, and process improvement methodologies.
• Knowledge of engineering and quality tools such as DOE, FMEA/PFMEA, CAPA, SPC, and root cause analysis.
• Proficiency in Microsoft Excel; experience with Minitab, JMP, or similar statistical software is preferred.
• Exposure to Lean Manufacturing, Six Sigma, Kaizen, or other continuous improvement methodologies is desirable.
• Strong analytical, technical writing, communication, teamwork, and problem-solving skills.

• Comply with all applicable quality procedures, regulatory requirements, and documentation standards.
• Support Quality System compliance while maintaining a strong commitment to product quality and patient safety.