Engineer - Quality (Medical Device) (Tijuana)

Position Summary

The Molding Engineer is responsible for identifying, owning and driving injection molding improvements through adherence to established product design, scientific injection molding process, tooling, resin, and equipment. The key responsibility of this position is to be proactive, identify, and execute injection molding activities, manage large scale projects, and drive change to prevent future complaints and manufacturing challenges. It is expected that the Molding Engineer completes complex engineering projects with peer input and guidance from engineering management. They will work on advanced, complex technical projects or business issues requiring state of the art technical or industry knowledge. Work will be accomplished autonomously where goals are generally communicated in solution or project goal terms. The Molding Engineer will consistently make decisions regarding the overall goals and objectives of significant programs or segments of the organization and may provide a leadership role for the work group through knowledge in the area of specialization. They will work directly with management to turn product strategy into action.

Essential Duties & Responsibilities

• Develops project direction together with management. Accepts the highest level of accountability.
• Analyzes, evaluates and plans methods for the solution of complex problems.
• Conducts investigations of considerable complexity pertaining to the development of new designs, methods, materials or processes, and investigates possible applications of the results.
• Defines parameters and boundaries for lower-level design activities. Establishes metrics for key aspects of system performance.
• Requires multi-disciplinary expertise or in-depth knowledge in a single discipline.
• Represent Molding Engineering to identify possible product modifications to improve manufacturing ability and impact on automation equipment.
• Initiate and manage projects with adherence to program management guidelines as they relate to new/existing molding equipment, tooling, and materials.
• Implement Molding Engineering activities such as scientific injection molding process development and process monitoring.
• Close coordination with all resources assigned to all product families (tool room, Process Engr, Quality Engr).
• Implement Cost Savings - Scrap, De-Cavitation, DPM, OEE.
• Maintain Product specifications; consult with manufacturing on product non-conformance.
• Lead project timelines for Validation (IQ/OQ/PQ) activities and growth/expansion projects.
• Coordinate efforts with the Materials to assess vendors and provide materials information.
• Spearhead initiatives for continuous process and product improvements (assess tolerance stack up of sustaining designs to increase robustness).
• Network to build a successful network internal and external to the company.
• Analyze and spec equipment performance and identify system improvements like vision systems, temperature controllers, robots, and resin analysis.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus.

Minimum Qualifications, Education & Experience

• Bachelor's degree from an accredited college or university.
• 2-4 years of experience similar role in medical device manufacturing industry.
• Understanding of strength of materials, automation, thermoplastic and LSR injection molding, part assembly, fixturing, testing, and process control techniques.
• Risk Management-> FMEA generation.
• Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) - use of Minitab Software for analysis.
• Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations.
• Master Molder training / certification or proof of understanding of the Scientific Injection Molding model; process, tooling, part design, materials, and equipment.
• Company leader in your domain of expertise. Quickly and easily obtain effective expertise within scope of influence.
• You have deep knowledge of best practices. Has subject matter expertise on engineering discipline.