Sr. Manufacturing Engineer

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

For Manufacturing services in the Engineering a rea.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Mechanical, Electrical, Industrial, Manufacturing, or Biomedical Engineering, or a related technical field, and 5–7+ years of experience in an FDA-regulated environment.
• Shift: Administrative and according to business needs.00
• Experience in:
  • IQ/OQ/PQ and process performancequalification, including validationprotocols, reports, and mastervalidation plans
  • DOE, PFMEA, riskanalysis, SPC, and MSA
  • Root-causeinvestigation and CAPA
  • Strongworking knowledge of 21 CFR Part 820,GMP, and ISO 13485

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Lead IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.
• Design and develop in-process and receiving inspection systems, control plans, sampling plans, and inspection methods for components and manufacturing processes.
• Generate, review, and approve equipment documentation, PM/calibration procedures, manufacturing instructions, and process control documentation.
• Manage enterprise manufacturing projects from concept through implementation; lead cross-functional technical collaboration with Manufacturing, Quality, R&D, Regulatory, Supply Chain, and external suppliers as applicable.
• Apply DOE, PFMEA, risk analysis, SPC, MSA, and root-cause methodologies to characterize, optimize, and improve manufacturing processes.
• Lead Lean Manufacturing and continuous improvement initiatives to improve yield, cycle time, cost, throughput, process capability, and equipment performance.
• Provide technical direction for manufacturing technologies, including laser welding, heat bonding, injection molding, vision systems, fixtures, tooling, test methods, automation, and equipment qualification.
• Support change control, CAPA, nonconformance investigations, and product/process scale-up activities while maintaining compliance with site quality procedures.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!