Manufacturing Engineering Section Leader

Responsibilities

• Provide leadership to engineering staff regarding project prioritization, process validations, and continuous improvement activities.
• Lead the team to maintain Key Performance Indicators (KPIs) and allocate engineering resources according to business needs.
• Perform installation and validation activities for new or existing production lines, including equipment, process, product, and test method validations.
• Manage equipment lifecycle by coordinating calibration, maintenance, and repair services while analyzing performance trends.
• Ensure manufacturing compliance with FDA, GMP, and ISO regulations and support CAPA investigation processes.
• Lead complex projects such as new product introductions, substantial product changes, and line expansions.
• Participate in cross-functional teams (RA, R&D, QA) and lead global initiatives with other sites.

Requirements

• Bachelor’s Degree in a STEM field.
• 7+ years of manufacturing or process development experience.
• Proficiency with statistical techniques such as DOE and SPC.
• Experience with continuous improvement methodologies (e.g., Lean Manufacturing, Value Stream Mapping).
• Solid knowledge of FDA, GMP, and ISO regulations.
• Experience leading validation plans for medical industry products and processes.
• Proven experience in project management and coordinating cross-functional teams.
• Fully bilingual in English and Spanish.
• Willingness to travel (approximately 5%).

Preferred Qualifications

• 5+ years of experience specifically in medical device manufacturing.
• Experience in performance management and supervising personnel.

About the Company

Abbott is a global healthcare leader dedicated to creating breakthrough science to improve people’s health. For over 135 years, we have been advancing innovative technologies in diagnostics, medical devices, nutrition, and branded generic medicines to help people live their best lives.