Edwards Lifesciences Principal Packaging Engineer in Salt Lake City, Utah
Apply knowledge of packaging materials, manufacturing methodologies, and the distribution environment hazards to sustain and develop sterile barrier packaging solutions that meet medical device design requirements for ISO11607 -1,2.
Interface with Edwards business unit product development and marketing partners to bring innovative package solutions to our product portfolio additions.
Develop and implement productivity and cost improvement initiatives, as part of Global Supply Chain packaging VIP programs and initiatives.
Apply a structured approach to problem solving and optimization using tools such as DMAIC, DOE, etc.
Develop, execute, and document Design Verification test protocols against design requirements using risk based sampling plans including package shelf life studies.
Draft and execute statistically based Installation, Operation, and Performance Qualifications on packaging equipment for globally based manufacturing operations.
Provide guidance, subject matter expertise, and oversight for packaging efforts in multiple manufacturing facilities, including Irvine, Draper, Singapore, Costa Rica, Añasco, Puerto Rico and Haina, Dominican Republic.
Interface with R&D, manufacturing, clinical affairs, quality and regulatory personnel to ensure compliance with internal and external policies and procedures, Edwards Quality System Requirements, and FDA and MDD regulations.
Drive new packaging technologies and strategies to improve time to market with a focus on Functional Excellence and Value Expansion to develop world-class capabilities and provide a competitive advantage to GSC.
Help support and drive new packaging technologies and strategies to improve time to market and advance the technology of package engineering at Edwards.
Qualifications - External
Required Skills, Experience and Education:
Must have a required minimum of eight (8) years related packaging experience.
Requires a bachelor's degree in Packaging, Mechanical, or other Engineering or Science discipline.
An advanced degree may substitute for some years of experience.
Must be able to work with limited supervision, think critically, and make calculated decisions based on sound risk based analysis and business needs.
Must have working knowledge of ISO11607 Part 1 and Part 2 with experience in the medical device, biotechnology or pharmaceutical manufacturing environment.
Strong understanding of engineering fundamentals, and a demonstrated ability to deconstruct real world issues into root engineering causes.
Solid knowledge of statistics is a must, including usage of statistical software, such as Statgraphics or Minitab is required;
6-sigma training & qualification is preferred.
Prior experience with FDA submissions Design Control Requirements per FDA 21 CFR 820.30 and ISO13485 is preferred.
Strong English communication skills are essential. Conversational Spanish language skills are a plus.
Detailed knowledge of methods of sterilization and design requirements for medical device packaging – irradiation
(Gamma or E-beam), or EtO, or Steam (Autoclave) is required.
Must have expert knowledge of Design Control and Risk Management, ISO, AAMI, EN868 and ASTM industry standards as well as domestic and international regulatory and government requirements and regulatory path such as FDA, or KEMA, or TUV, or TGA is required.
Must demonstrate a strong working knowledge of standardized package testing and good working knowledge of device regulatory requirements.
Successful completion of an academic program or having past work experiences which provide a detailed technical knowledge of performance and compatibility of common medical device packaging materials and adhesives such as
Tyvek, or HIPS, or PETG, or Polycarbonate, or Polyolefin's, or co-ex films as well a detailed knowledge of material forming processes such as thermoforming, or injection molding, or extrusion/extrusion blow, or FFS is desired.
- Solid technical writing skills and knowledge of documentation requirements in a highly regulated industry is also required.
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 13,000 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.