This position has a New Product Development focus and will provide overall packageengineering support for new product development teams. Prototype, design, develop and validate packaging systems to primarily supportclinical trials, limited market releases and commercial product launches. Specifically the incumbent will provide R&D packageengineering & project management support for new product launches,clinical trials, global and limited market releases as well as key operations initiatives. Drive new packagingtechnologies 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 Edwards.
- Key activities for this position will include developing and executing protocols for package design, packaging processes validation and package shelf life testing. Support and drive new packaging technologies and strategies to improve time to market and advance the technology of package engineering at Edwards.
- Works through continuous changes resulting from a dynamic product development environment and translate the device changes into the package development process, working closely and continuously with cross-functional team members and outside suppliers of materials and services.
- Validates packaging equipment and packaging manufacturing processes. Source, purchase, install and validate equipment as well as develop and validate packaging processes.
Qualifications Requires a minimum of fiveyears’experience in packageengineering. An advanceddegree may substitute for someyears of workexperience. Bachelor'sdegree isrequired, preferably in PackageEngineering, but will consider a relevant scientific orengineeringdegree. A Master'sdegree in Business Administration or PackageEngineering,Engineering, or related science/technicaldegree field ispreferred.
- Experience in a medical device, biotechnology or a pharmaceutical environment is preferred.
- Experience in an FDA regulated industry, preferably medical device is optimal.
- Must have expert knowledge of Design Control and Risk Management, ISO, AAMI, EN868 and ASTM industry standards.
- Must demonstrate a strong working knowledge of standardized package testing and good working knowledge of device regulatory requirements.
- Ability to develop and execute protocols for package design, packaging processes validation and package shelf life testing, validate packaging equipment and packaging manufacturing processes; source, purchase, install and validate equipment as well as develop and validate packaging processes; support and drive new packaging technologies and strategies to improve time to market and advance the technology of package engineering - rapid prototype design & development
- Solid technical writing skills and knowledge of documentation requirements in a highly regulated industry is also required.
- Ability to utilize the principles of rapid prototyping to support clinical and commercial NPD timelines - quickly assess design input requirements and translate into design outputs, concept drawings and prototypes and eventually into fully transferable package design and process to support speed to market.
- Experience using design input gathering tools (i.e. VOC and DFM tools) is essential.