Sr. Manufacturing Engineer

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. 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?