Sr. R&D Engineer/Project Engineer (Plastics)

The Sr. R&D Engineer/Project Engineer (Plastics) is responsible for leading and coordinating process development activities to support new product development, sustain engineering efforts, including cost reduction, and design/manufacturing.

Responsibilities:

• Plans and leads process development activities, including design, prototyping, testing (verification and validation), process risk management/FMEA, process characterization, and documentation.
• Provides technical expertise in new tool development, processing guidance, and troubleshooting.
• Interacts with suppliers to define and evaluate materials and processes required for the effective execution of process development activities, and debug issues with part production processes and equipment.
• Advises other engineering personnel on technical aspects of product/process design, molding techniques, and process validation.
• Develops a comprehensive manufacturing strategy for all projects, which includes alternative methods for component procurement, timing, costs, capital, expenses, risks, and recommendations.
• Responsible for validations, IQ/OQ/PQ, and production of products within the agreed scope, budget, schedule, and quality.
• Coordinates with SBU planning for initial and ongoing supply, safety stock, and distribution management, including shelf life and alternate suppliers for critical components.
• Together with Quality, establishes AQL levels for each component and incoming inspection criteria, including location, measurement methods, consistent data recording, and disposition.
• Coordinates all product transfers to TFX plants and/or alternate manufacturing sites.
• Uses metrics to improve new production, introduction processes, and product quality at launch and throughout the life of the program.
• Works with project management to ensure that all components/documents are correctly placed in SAP and Agile.

Minimum Requirements:

• Bachelor’s degree in Engineering or Master’s degree (preferred).
• 5+ years of previous experience in a related field (medical device manufacturing and assembly, disposables manufacturing processes, plastics, injection molding, and automation).
• Bilingual (English/Spanish) communication and presentation skills (both written and spoken).
• Ability to work effectively with other product development team members.
• Proficiency in SAP and Agile (preferred).
• High attention to detail and the ability to work in a fast-paced environment.
• Strong communication and collaboration skills.
• Experience in the medical industry and knowledge of ISO 13485.

Position for transfer project.

The workplace is located in Tecate, Baja California.