Sr. Manufacturing Engineer

For Manufacturing services in the Engineering area.

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.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative and according to business needs.00
• Experience in:
  • IQ/OQ/PQ and process performance qualification, including validation protocols, reports, and master validation plans
  • DOE, PFMEA, risk analysis, SPC, and MSA
  • Root-cause investigation and CAPA
  • Strong working 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 company different 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 industry clients with top-notch quality talent. We're FITS!

Are you the next piece?