Senior Packaging Engineer

hace 2 semanas

Tijuana, Baja California, México ICU Medical A tiempo completo

Position Summary

The Senior Packaging Engineer is responsible for supporting and driving packaging related projects through adherence to established quality system requirements, design control processes, good engineering, and documentation practices. The key responsibility of this position is to exercise medical device packaging subject matter expertise, sound judgement and take action while adhering to defined procedures during project support & improvements.

The Packaging Engineer will complete engineering projects with input and guidance from senior level engineers and managers. Will gain exposure to some of the complex tasks within the job function.

Essential Duties & Responsibilities

  • Responsible for the development and analysis of sterile or non-sterile barrier components and assemblies for medical devices
  • Ensure proposed packaging design changes are systematically and thoroughly analyzed through proper justification and/or data collection for verification of performance requirements
  • Identify and implement process and product modifications to improve manufacturability and profitability
  • Consult with Manufacturing and Quality Engineers on in-process packaging related non-conformances
  • Support project timelines and milestones and bring them to completion on time and within budget
  • Assist in completion of CAPA tasks and deliverables (Corrective and Preventive) as assigned
  • Initiate and manage projects with adherence to program management guidelines
  • Conducts independent analysis and develops solutions to problems
  • Writes detailed technical documentation
  • Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration
  • Work on special projects as they arise

Knowledge, Skills & Qualifications

  • Proficient in packaging engineering, structured problem solving, use of statistical tools (proficiency will align with job level)
  • Proficient knowledge of external packaging standards and methods such as ISO , ISO , ASTM D4169, etc. (proficiency will align with job level)
  • Knowledge of the Medical Device Industry and familiarity with FDA QSR Regulations is a plus
  • Competent in your domain. Familiar with other areas of domain expertise within the team (competency will align with job level)
  • Has a basic understanding of best practices. Has a good understanding of engineering discipline
  • Has awareness of the broader product strategy and contribute to it
  • Ability to receive general project direction and solicit input from more experienced engineers.
  • Requires the ability to independently make decisions that impact the attainment of the project

Minimum Qualifications, Education & Experience

  • Bachelor of Science degree from an accredited college or university in Packaging Engineering or a related field.
  • 3-8+ years of experience in Medical Device Packaging (experience will align with job level)

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