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Principal Engineer, Packaging Request ID: Req-21719 Location: USA, California, Irvine

Employer
Edwards Lifesciences
Location
Irvine, CA
Closing date
Feb 8, 2023

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Job Description Summary:

The Principal Packaging Engineer will support our GSC (Global Supply Chain) Packaging Engineer team by providing technical expertise on packaging projects and operations improvement initiatives for medical devices.

Key Responsibilities:
  • Lead packaging design and development projects for new or improved solutions, full commercial launches, and operations improvement initiatives.
  • Lead cross-functional packaging projects across multiple sites/regions with interdepartmental personnel such Regulatory Affairs, Manufacturing, Operations, Quality, Supply Chain among others.
  • Create, review, and approve protocols for package design, packaging process validation, and package shelf-life testing in accordance with internal procedures and industry guidelines; may oversee the work of engineers in the development of technical documentation and create goals and objectives for team to support company's KODs.
  • Provide strategic and technical direction and establish project plans for projects by working closely with senior leadership, cross-functional team members, outside suppliers and consultants.
  • Oversee technical packaging work performed by lower-level engineers - e.g., design, prototyping, testing, process design and development, equipment deployment and validation.
  • Provide technical packaging expertise for medical initiatives and/or product submissions.
  • Release of documentation through internal ECR procedure.
  • Interface with vendors on technical issues and perform duties in compliance with applicable FDA as well as international standards.
  • Identify Value Improvement Projects (VIP).
  • Other incidental duties


Minimum Qualifications:
  • Bachelor's degree in Engineering or Scientific field with a minimum of six (6) years of packaging experience OR
  • Master's Degree in in Engineering or Scientific field with a minimum five (5) years of packaging experience OR
  • Ph.D. in Engineering or Scientific field plus a minimum of two (2) years of experience in packaging


Preferred Skills:
  • Excellent technical documentation and communication skills and interpersonal relationship skills including consultative and relationship management skills with ability to drive achievement of objectives
  • Good understanding of statistical techniques
  • Previous experience working with lab/industrial equipment required
  • Working knowledge of packaging materials, sterilization methods, test methods, process validation and international standards related to sterile medical device packaging.
  • Experience in production environment.
  • Excellent problem-solving, organizational, analytical and critical thinking skills
  • Extensive understanding of processes and equipment used in assigned work
  • Skilled in leading and facilitating change, including collaboration with management and stakeholders
  • Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
  • Strict attention to detail
  • Ability to manage competing priorities in a fast-paced environment
  • Ability to represent the organization in providing solutions to difficult technical issues associated with specific projects

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $106 000 to $151 000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

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