Engineer Ii Manufacturing-2 (Ciudad Juárez)

Overview

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Values : Customer – We focus on our customers’ success; Innovation – We create better solutions; Collaboration – We create success together; Inclusion – We always interact with others respectfully; Candor – We are open and honest with one another; Integrity – We do the right things and do things right.

Responsibilities

• Supports ongoing production operations and is the primary technical support resource for production lines. Typically, works directly with production associates daily to support process and equipment as well as responds to resolve technical issues that arise during production operations.
• Develops, details, and implements process and equipment solutions which improve safety, quality, delivery and cost on existing production lines.
• Develops and procures tooling, fixtures, and equipment used in manufacturing that optimize productivity, maintainability, and cost.
• Creates and maintains manufacturing documents and digital operations systems (IIOT systems) including engineering drawings, BOMs, routers, process work instructions, engineering change orders, and MES configuration modeling.
• Leads equipment qualification and process validation tasks.
• Collaborates with cross-functional teams to evaluate and influence designs for manufacturability, cost reduction and business growth projects.
• Interacts with manufacturing, quality and supply chain associates to identify process improvement opportunities and to evaluate/disposition non-conforming products as needed.
• Establishes and executes corrective and preventative action plans to remediate system quality or operational concerns and proactively takes action to mitigate potential for production operations failures. Participates in cross-functional project teams to implement creative solutions.
• Monitors performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
• Interfaces with Quality and R&D to integrate new products or processes.
• Responsible for identifying and correcting manufacturing process nonconformance’s identified during prototype builds. Works with the product monitoring group on complaint investigations and supports the DPRA process. CAPA owner for any CAPA’s related to the design of the product.
• Medical devices validation knowledge as IQ, OQ, PQ, PPQ, TMVs is required.
• Coordinates with the manufacturing site on product transfers by leading the design transfer process. Supports the manufacturing site on any design or process related changes. Supports the supplier quality team on for supplier changes that might impact the product design.
• Fluent in English, with good knowledge of statistical analysis and AutoCAD for layout design.
• U.S. Applicants: EOE/AA Disability/Veteran

Qualifications

• Strong understanding of manufacturing processes and production support.
• Experience with process development, equipment qualification, and process validation activities in a manufacturing environment.
• Ability to develop and procure tooling, fixtures, and equipment; familiarity with IIoT systems; proficiency with engineering drawings, BOMs, routers, process work instructions, and MES configuration.
• Experience in cross-functional collaboration with manufacturing, quality, and supply chain teams.
• Problem-solving skills with capability to identify root causes, implement CAPA, and drive continuous improvement.
• Knowledge of regulatory and quality concepts related to medical devices (IQ/OQ/PQ/PPQ, TMVs) preferred.
• Strong written and verbal communication, and proficiency in statistical analysis; proficiency with AutoCAD.