*position summary*we are seeking an experienced manufacturing director to lead and optimize our tijuana-based manufacturing operations for (medical devices / healthcare products / pharmaceuticals).this role is responsible for delivering high-quality products on time, within budget, and in full compliance with fda, iso *, and mexican regulatory requirements.*key responsibilities*strategic leadership*- develop and execute the manufacturing strategy to support corporate growth objectives.- lead annual operational planning, capacity expansion, and capital investment projects.- foster a culture of safety, quality, and continuous improvement across all teams.*operational management*- oversee daily production, maintenance, planning, and warehouse activities.- ensure compliance with good manufacturing practices (gmp), iso *, and fda/cofepris requirements.- manage operational kpis for on-time delivery, quality yield, cost efficiency, and scrap reduction.*people & culture*- lead, coach, and develop plant managers, supervisors, and cross-functional teams.- drive employee engagement and retention through effective communication, training, and recognition programs.- promote bilingual/multicultural collaboration across u.s. and mexico operations.*quality & compliance*- partner with the quality department to ensure products meet or exceed regulatory and customer expectations.- support audits from regulatory agencies and customer quality teams.- maintain all necessary certifications and documentation for medical manufacturing compliance.*cross-border & cross-functional collaboration*- coordinate closely with u.s. headquarters on production forecasts, new product introductions, and operational updates.- collaborate with engineering, supply chain, and r&d teams for process improvements and technology transfers.- ensure smooth communication and workflow between facilities across the border.*qualifications*- bachelor's degree in engineering, industrial engineering, manufacturing, or related field (master's preferred).- 10+ years of progressive manufacturing leadership experience, with at least 5 years in the medical device, pharmaceutical, or other highly regulated industry.- proven success in lean manufacturing, six sigma, and operational excellence initiatives.- strong understanding of fda, iso *, gmp, and cofepris requirements.- experience managing operations in mexico, preferably within the tijuana maquiladora sector.- bilingual - fluent in english and spanish (written and verbal).- strong financial and analytical skills for managing budgets, cost control, and roi analysis.*key competencies*- strategic vision with hands-on leadership style- exceptional communication and negotiation skills- ability to influence across cultural and organizational boundaries- data-driven decision-making- commitment to safety, quality, and ethical practices