Senior Engineer, Packaging

Edwards Lifesciences; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Packaging Engineer to design and validate packaging for medical devices, from concept through launch. You’ll work with cross-functional teams to advance packaging technology and ensure compliance with design controls and ISO standards.

The role requires a technical degree with 4+ years in packaging, plus experience with windchill PLM and statistical methods. You’ll mentor junior engineers and drive quality improvements in a fast-paced environment.

Qualifications

• Bachelor's degree in Engineering or Scientific field with minimum of 4 years industry experience.
• Master's Degree or equivalent in Engineering or Scientific field with minimum of 3 years industry experience.
• Strong written and verbal communication and interpersonal skills; collaborate effectively across technical and cross-functional teams.

Responsibilities

• Design packaging concepts for complex projects, including new product launches and existing products from concept to launch.
• Develop packaging design protocols, validation, and shelf life testing; drive new packaging technologies.
• Develop plans for complex projects with cross-functional teams and outside suppliers.
• Validate packaging equipment and processes for sourcing, installation planning and specifications.
• Provide guidance to lower level engineers.
• Other incidental duties assigned by Leadership.

Skills

Cross-functional collaboration

Engineering judgment

Communication skills

Packaging development leadership

Education

Bachelor's degree in Engineering or Scientific field

Master's degree in Engineering or Scientific field

Tools

Windchill PLM

Minitab

Job description

USA - California - Irvine

Full time

Req-51595

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

This is an exciting opportunity with the World Wide Engineering team currently involved in cutting edge packaging design & development leveraging applied research in design, materials and modeling. As a Packaging Engineer you will work closely with other engineers to develop world-class capabilities and provide a competitive advantage to Edwards, through packaging design including component e.g. thermoform trays, injection molded parts, pouches and shelf & shipper boxes.

How you’ll make an impact:

• 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 guidance and coaching to lower level engineers.
• Other incidental duties assigned by Leadership.

What you’ll need (Required):

• Bachelor's Degree in Engineering or Scientific field with minimum of 4 years either industry or industry/education experience or
• Master's Degree or equivalent in Engineering or Scientific field with minimum of 3 years either industry or industry/education experience.

What else we look for (Preferred):

• Ability to effectively manage multiple priorities and deliver results in a fast-paced, cross-functional environment.
• Demonstrated ability to apply engineering principles, critical thinking, and sound technical judgment to solve complex engineering challenges.
• Strong written and verbal communication and interpersonal skills, with the ability to collaborate effectively across technical and cross-functional teams (influence technical direction, resolve design, manufacturing, and quality challenges).
• Demonstrated experience independently leading packaging development and validation activities for medical devices or other highly regulated products.
• Strong understanding of design controls and the product development lifecycle for new product development.
• Demonstrated 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 applicable 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 lab test methods (e.g. peel strength, submersion leak, dye penetration, etc).
• Proven experience with material selection and design of packaging systems, including thermoformed trays, flexible pouches, lidding materials, injection-molded components, and/or corrugated/paperboard cartons.
• Strong supplier-management skills with the ability to provide technical direction and resolve design, manufacturing, and quality challenges.
• Working knowledge of statistical methods and data analysis tools (e.g. Minitab).
• Experience using Windchill PLM system or relevant PLM experience.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety, & Quality rules/guidelines) 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.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $108,000 - $153,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.