Edwards Lifesciences Principal Packaging Engineer in Salt Lake City, Utah
Provide technical expertise on packaging projects and operations improvement initiatives. This position is part of the GSC Packaging Engineering team.
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.
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
- Bachelor’s degree in Engineering or Scientific field with a minimum eight years of packaging experience or Master's Degree in Engineering or Scientific field with a minimum seven years of packaging experience or Ph.D. in Engineering or Scientific field plus a minimum of six years of experience in packaging
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 a high mix / low volume 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 interact professionally with all organizational levels
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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.