Manufacturing Engineer: Process Validation & Lean

Inteldot; Dorado (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Inteldot invites applications for a Manufacturing Engineer in Puerto Rico, onsite. The role supports manufacturing operations by assisting with process validation, documentation, data analysis, and continuous improvement initiatives in a regulated setting.

You will work with senior engineers and cross‑functional teams to develop, optimize, and qualify manufacturing processes, ensuring compliance with quality systems and regulatory requirements.

Qualifications

• Bachelor's degree in an engineering discipline required.
• 1–3 years in Manufacturing/Process/Quality engineering in a regulated setting preferred.
• Knowledge of FDA QSR (21 CFR Part 820), GMP, ISO 13485 preferred.

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

Strong analytical & problem-solving

Technical writing

Communication & teamwork

Education

Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or related field

Tools

DOE

FMEA/PFMEA

CAPA

SPC

Root cause analysis

Excel

Minitab

JMP

Job description

Inteldot invites applications for a Manufacturing Engineer in Puerto Rico, onsite. The role supports manufacturing operations by assisting with process validation, documentation, data analysis, and continuous improvement initiatives in a regulated setting.

You will work with senior engineers and cross‑functional teams to develop, optimize, and qualify manufacturing processes, ensuring compliance with quality systems and regulatory requirements.