Coordinates and oversees Manufacturing Engineering activities ensuring they meet applicable regulatory requirements and internal business requirements, and assuring they achieve the set goals of efficiency, effectiveness and compliance. Liaison with other Business and Functional Managers throughout the organization, to ensure activities are being properly planned, implemented, executed, and maintained, meeting their expectations.
Build and develop high-performing teams with technical expertise, innovation, and core competencies aligned to strategic goals.
Enhance manufacturing and process engineering through intentional talent selection, training, and development.
Deliver compliant engineering solutions using methodologies like Corrective and Preventive Actions, Statistical Process Controls, and Six Sigma, adhering to FDA QSR and ISO 13485 standards.
Collaborate with Supplier Quality, Supply Chain, and Strategic Sourcing to optimize vendor selection, pricing, and supply chain design.
Support validation activities and ensure process and equipment qualifications meet required standards.
Oversee capital equipment acquisition, ensuring ROI and proper application of engineering principles in project execution.
Provide production support to meet performance, quality, cost, and capacity targets, offering training and ensuring effective resource allocation.
Drive workplace safety, ergonomics, project management excellence, and compliance with company policies while managing budgets and continuous product quality improvements.
What you will need:B.S. engineering (mechanical, electrical, or industrial)
Minimum of 7 years of experience on engineering or technical function
3+ years of management experience
3+years of project management experience
Experience in the medical industry
Demonstrated ability to develop detailed process plans using applicable tools (PFMEA, Fault Tree Analysis, and Safety and Efficacy reviews)
Demonstrated ability to implement qualified processes using applicable systems (Process Validation, Process Planning Tools, Design of experiments, Manufacturing Assembly Procedures)
Bilingual: English/Spanish.
Travel Percentage: 10%