Operations Engineering Manager

Requirements: Degree in Electronics, Industrial, Mechatronics, Biomedical Engineering or related field. 8 years of experience in medical and electronic manufacturing. 3 years in a leadership role. Intermediate to advanced English proficiency. 100% on-site position. Hard Skills: Strong knowledge and experience with ISO 13485 and FDA 21 CFR Part 820 regulations. Solid understanding and experience with 21 CFR Part 11: Electronic Records; Electronic Signatures. Experience with IQ/OQ/PQ protocols and regulatory compliance. Knowledge and experience with IPC-6012 / IPC 7711/7721 standards. Experience in electronic manufacturing processes. Experience in medical device manufacturing processes. Process control expertise. Experience in new product introduction, process improvement, and technical validations. Solid knowledge of Clean Room Class 7 & Class 8 environments. Strong understanding of ISO 13485, FDA 21 CFR Part 820, and ISO 14644 for clean rooms. Proven experience optimizing efficiency, yield, and OEE. Strong background in implementing Lean and Six Sigma tools. Soft Skills: Strong leadership and personnel management experience. Solid planning and organizational skills. Proven experience in quality management and continuous improvement. Critical thinking and problem-solving abilities. Effective communication and negotiation skills.

Location: Monterrey Metropolitan Area, MX

Posted Date: 10/27/2025