Expected to drive and manage multiple projects for supporting the needs for sustaining packaging engineering of the manufacturing sites, and developing and improving packaging solutions to Edwards's packaging operation. The position plays a key role in working with various project teams to ensure compliance, sustain product life cycle, transfer new product development to production and generate packaging cost saving and/or value added engineering projects.
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.to our product portfolio additions.
Develop and implement productivity and cost improvement initiatives, as part of packaging operations
Improvement 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 and Costa Rica.
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.
Qualifications - External
Required Skills, Experience and Education:
Must have a required minimum of four (4) 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;
Lean and 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..
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 DEKRA, 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 Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs about 8,200 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences Corp