Edwards Lifesciences Sr Packaging Engineer, New Product Development in Irvine, California
Develop world-class capabilities and provide a competitive advantage to Edwards, through packaging design and project management.
Design innovative packaging concepts for complex projects, including new product launches and existing products throughout all stages of product development from concept to launch, including clinical trials, global and limited market releases, as well as key operations initiatives
Develop protocols for, and implement, package design, packaging process validation, and package shelf life testing, as well as driving new packaging technologies and strategies with increased uncertainty and complexity, to improve time to market and advance the technology of package engineering at Edwards
Develop plans for complex projects working closely with cross-functional team members and outside suppliers
Validate new packaging equipment and packaging manufacturing processes to determine appropriate sourcing, purchasing, installation planning and specifications
Provide mentorship and coaching to lower level engineers
Other incidental duties assigned by Leadership
Education and Experience:
Bachelor's Degree in Engineering or Scientific field, preferably in Packaging + minimum of 4 years’ experience in industry is required
Master's Degree or equivalent in Engineering or Scientific field, minimum of 3 years’ experience either industry or industry/education experience Required or
Ph.D. or equivalent in Engineering or Scientific field No experience Required
The packaging engineer must demonstrate a strong working knowledge of standardized package testing, industry standards such as ISO, ASTM and AAMI and good working knowledge of device regulatory requirements.
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 is desired.
Ability to develop and execute protocols for package design, process validation and shelf life.
Proven expertise in usage of MS Office Suite and related statistical knowledge for packaging; CAD experience preferred
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
Strong problem-solving, organizational, analytical and critical thinking skills
Meaningful understanding of processes and equipment used in assigned work
Good leadership skills and ability to inspire change
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 handle competing priorities in a fast-paced environment
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.