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Packaging Engineer CA Open (J#29785)
Education: Bachelors Degree
Experience: 1 - 3 years

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 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 7,000 individuals worldwide.

For us, helping patients is not a slogan it's our lifes 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 help ensure that patients regain and even improve their quality of life.
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Opportunity Snapshot:

The Senior Packaging Engineer has a New Product Development focus and will provide overall package engineering support for new product development teams. Responsibilities for this position include:

- Prototype, design, develop and validate packaging systems to primarily support clinical trials, limited market releases and full scale product launches.
- Specifically the incumbent will provide R&D package engineering and project management support for new product launches, clinical trials, global and limited market releases as well as key operations initiatives.
- 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 Edwards.

Key activities for this position will include:
- Developing and executing protocols for package design, packaging processes validation and package shelf life testing.
- Help support and drive new packaging technologies and strategies to improve time to market and advance the technology of package engineering at Edwards.
- Working 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.
- Validating packaging equipment and packaging manufacturing processes. Source, purchase, install and validate equipment as well as develop and validate packaging processes.

Our Requirements:

*Multi-level position: Position title and level posted is preferred. However, depending on experience and background, we will consider hiring within these levels: Packaging Engineer II; Sr. Packaging Engineer; Staff Packaging Engineer.

- The Packaging Engineer II requires a minimum of two years package engineering experience; the Sr. Packaging Engineer requires a minimum of four years package engineering experience; and the Staff Packaging Engineer requires a minimum of five years package engineering experience.
- Experience in a medical device, biotechnology or a pharmaceutical environment is preferred but not required. Experience in an FDA regulated industry, preferably medical device is optimal.
- Knowledge of methods of sterilization and design requirements for medical device packaging is also preferred.
- A Bachelor's degree is required, preferably in Package Engineering, but will consider a relevant scientific or engineering degree. A Master's degree in Business Administration or Package Engineering, Engineering, or related science/technical degree field is preferred.

- The packaging engineer 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.
- 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.

How to Apply:

At Edwards Lifesciences, we want you to have as much information as possible before making an important career decision. To find out more about this role and the opportunity it offers, please visit our website:
www.edwards.com

OR

To apply directly to this position, please click the link below or cut and paste it into your browser:
www.edwards.com/Careers/reqfinder?urlvariablestring=5458

***Note to Agencies and Recruiters: Edwards Lifesciences is not accepting referrals from Agencies or Recruiters.

Resumes received by Edwards Lifesciences from search firms and/or individual recruiters are considered unsolicited.

Agencies and Recruiters: Refrain from contacting managers directly, to solicit job orders. Contact the Edwards Lifesciences Human Resources Department via e-mail at EW_Talent_Acquisition@edwards.com or call our dedicated Talent Acquisition hotline at 949-250-3422. Thank you.

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