Note: The job is a remote job and is open to candidates in USA. Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. The Manufacturing Engineer supports manufacturing operations by assisting with process validation, documentation, data analysis, and continuous improvement initiatives.
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
Skills
- Bachelor's degree in mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or a related engineering discipline
- 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
- Strong analytical, technical writing, communication, teamwork, and problem-solving skills
- 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
- 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
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