Senior Manufacturing Engineer - Validation & Lean

FITS, LLC; Dorado (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

FITS, LLC is a Service Provider offering engineering and manufacturing support across the Island and US. We seek a senior engineer with strong experience in FDA-regulated environments to lead validation and process improvement activities.

You will design inspection systems, manage cross-functional projects, and drive continuous improvement using DOE, PFMEA, SPC, and CAPA methodologies to ensure quality and efficiency.

Qualifications

• Bachelor's degree in a relevant engineering field and 5–7+ years in an FDA-regulated environment.
• Experience with IQ/OQ/PQ, validation protocols, reports, and master validation plans.
• Proficiency with DOE, PFMEA, risk analysis, SPC and MSA.

Responsibilities

• Lead IQ/OQ/PQ and process validation activities; develop validation protocols and reports.
• Design in-process and receiving inspection systems, control plans, sampling plans, and inspection methods.
• Generate and approve equipment documentation, PM/calibration procedures, and manufacturing instructions.
• Manage enterprise manufacturing projects from concept to implementation; collaborate cross-functionally.
• Apply DOE, PFMEA, risk analysis, SPC, MSA and root-cause methodologies to optimize processes.
• Lead Lean Manufacturing and continuous improvement to improve yield, cycle time, and cost.
• Provide technical direction for manufacturing technologies (laser welding, injection molding, vision systems, automation).
• Support change control, CAPA, nonconformance investigations and scale-up activities with quality compliance.

Skills

FDA-regulated experience

IQ/OQ/PQ and validation protocols

DOE

PFMEA

Risk analysis

SPC

MSA

Root-cause investigation

CAPA

Lean Manufacturing

Education

Bachelor's degree in mechanical, electrical, industrial, manufacturing or biomedical engineering (or related field)

Job description

FITS, LLC is a Service Provider offering engineering and manufacturing support across the Island and US. We seek a senior engineer with strong experience in FDA-regulated environments to lead validation and process improvement activities.

You will design inspection systems, manage cross-functional projects, and drive continuous improvement using DOE, PFMEA, SPC, and CAPA methodologies to ensure quality and efficiency.