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-...