Senior Engineer, Packaging

Edwards Lifesciences•Irvine, CA

5d•$108,000 - $153,000

About The Position

This role is part of the World Wide Engineering team and focuses on packaging design and development, using applied research in design, materials, and modeling. The Packaging Engineer works with other engineers to develop packaging capabilities and support Edwards’ competitive position through designs for components such as thermoform trays, injection-molded parts, pouches, and shelf and shipper boxes. The role supports complex projects, new product launches, existing products, clinical trials, global and limited market releases, and operations initiatives from concept through launch. It also involves packaging process validation, shelf-life testing, packaging technologies, supplier collaboration, and coaching lower-level engineers.

Requirements

Bachelor’s degree in an Engineering or Scientific field and at least 4 years of industry or combined industry/education experience, or a master’s degree or equivalent in an Engineering or Scientific field and at least 3 years of industry or combined industry/education experience.
Proficiency with Microsoft Office Suite.
Working knowledge of CAD software.
Ability to manage multiple priorities and deliver results in a fast-paced, cross-functional environment.
Ability to apply engineering principles, critical thinking, and sound technical judgment to complex engineering challenges.
Strong written and verbal communication and interpersonal skills, including the ability to collaborate across technical and cross-functional teams and influence technical direction and resolve design, manufacturing, and quality challenges.
Adherence to company rules and requirements, including Environmental Health & Safety and Quality rules and guidelines.

Nice To Haves

Experience independently leading packaging development and validation for medical devices or other highly regulated products.
Strong understanding of design controls and the product development lifecycle for new product development.
Ability to develop technically sound test strategies, protocols, acceptance criteria, and reports supporting packaging design verification, process validation, and shelf-life claims.
Working knowledge of packaging standards and test methods, including ISO 11607 and relevant ASTM standards.
Experience with environmental conditioning and distribution simulation testing, including ASTM D4332 and ASTM D4169.
Knowledge of ASTM packaging laboratory test methods, such as peel strength, submersion leak, and dye penetration testing.
Experience selecting materials and designing packaging systems, including thermoformed trays, flexible pouches, lidding materials, injection-molded components, and/or corrugated or paperboard cartons.
Strong supplier-management skills and ability to provide technical direction and resolve design, manufacturing, and quality challenges.
Working knowledge of statistical methods and data analysis tools such as Minitab.
Experience using Windchill PLM or a relevant PLM system.

Responsibilities

Design packaging concepts for complex projects and products throughout development, from concept to launch, including clinical trials, global and limited market releases, and operations initiatives.
Develop protocols for and implement package design, packaging process validation, and package shelf-life testing.
Drive new packaging technologies and strategies to improve time to market and advance packaging engineering capabilities.
Develop plans for complex projects in collaboration with cross-functional team members and outside suppliers.
Validate new packaging equipment and manufacturing processes, including determining sourcing, purchasing, installation planning, and specifications.
Provide guidance and coaching to lower-level engineers.
Perform other duties assigned by leadership.
Follow company rules and requirements, including pandemic protocols and Environmental Health & Safety and Quality guidelines, and take measures to prevent injuries and pollution and protect the environment.