Sr. Manufacturing Engineer

FITS LLC; Dorado (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS LLC in Dorado, Puerto Rico is seeking a senior engineer with a Bachelor’s in Mechanical, Electrical, Industrial, Manufacturing, or Biomedical engineering and 5–7+ years in an FDA-regulated environment to lead IQ/OQ/PQ and process qualification activities.

You will design and implement inspection systems, control plans, sampling methods, and inspection procedures; drive Lean manufacturing, DOE, PFMEA, SPC/MSA, CAPA, and cross‑functional collaboration to ensure compliant, high‑quality

Qualifications

• Bachelor's degree in engineering with 5–7+ years in an FDA-regulated environment.
• Bilingual in English and Spanish.
• Project management skills.
• Shift: Administrative and per business needs.
• Experience in IQ/OQ/PQ and validation protocols, reports, and master validation plans.
• Experience with DOE, PFMEA, risk analysis, SPC, and MSA.
• Root-cause investigation and CAPA.
• Strong knowledge of 21 CFR Part 820, GMP, and ISO 13485.

Responsibilities

• Lead IQ/OQ/PQ and process 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.

Skills

Project Management

Bilingual English/Spanish

Quality systems

Education

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

Job description

WHAT MAKES YOU A FIT:

• 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.
• Bilingual (English & Spanish).
• Project Management skills.
• 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.