Manufacturing Engineer Director

Essential Duties and Responsibilities

• Develop and execute manufacturing process strategies related to technology, infrastructure, and equipment to ensure manufacturing operations provides a competitive advantage to the firm (manufacturing operations includes assembly packaging operations (APO) and injection molding operations (IMO)).
• Drives customer satisfaction by optimizing manufacturing processes to meet high standards for product quality, manufacturing productivity and delivery in full on time.
• Develop and submit investment plans and budgets in support of manufacturing process strategies. Investment plans to provide clear ROI analysis. Operating budgets include but are not limited to staff, capital, and expense.
• Cook with and coordinate with the R&D team for development of product manufacturing methods (PMM), processes, tooling, and molds necessary to produce new products and sustain existing products.
• Responsible for effective transfer of process designs to manufacturing operations.
• Assures when the output of a manufacturing process “cannot be fully verified by subsequent inspection and test the process shall be validated.” Examples include sterilization, injection molding and welding.
• Adhere to the quality management system and assure that all manufacturing processes meet FDA 21 CFR 820, ISO13485, and other applicable regulatory requirements.
• Establish and track progress against performance targets (KPIs) for critical manufacturing processes.
• Identify and qualify external suppliers in support of manufacturing processes.
• Hire, manage, coach, motivate and assess performance of manufacturing engineers, technicians, and managers by reviewing the performance plans and organizing necessary interventions for improvement.

Physical / Mental Demands

• Work under stress in a fast-paced environment.
• Must be alert, able to concentrate, and use good judgment.

Requirements

• A bachelor’s degree in engineering or another relevant field.
• Ten years of professional experience in manufacturing, including experience in a leadership role.
• Knowledge of manufacturing processes, organizational methodologies, and vendor relationship management.
• Strong computer proficiency and excellent communication skills.
• Ability to think critically and solve problems innovatively.
• Data-driven with the ability to read and interpret findings from a variety of sources.