Manufacturing Engineer

Inteldot•Dorado, PR

36d•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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.
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.