Sr Engineer, Packaging, Critical Care

1 month ago

Irvine, United States Edwards Lifesciences Full time

For over 50 years, the Critical Care business within Edwards has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology. If you're eager to contribute your expertise and commitment to Critical Care’s mission, we invite you to explore these career opportunities. Those who join us or continue their current journey within Critical Care will play their own part in improving the quality of care and outcomes for millions of patients around the world. You will make an impact by... Designing innovative packaging concepts for moderately 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. Developing 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. Developing plans for moderately complex projects working closely with cross-functional team members and outside suppliers. Validating packaging equipment and packaging manufacturing processes to determine appropriate sourcing, purchasing, installation planning and specifications. Providing guidance and coaching to lower level engineers. Other incidental duties assigned by Leadership. What you'll need: Bachelor's Degree in Engineering or Packaging Degree, + minimum of 4 years’ experience is required or Master's Degree or equivalent in Engineering or Packaging Degree, minimum of 3 years’ experience is required or Ph.D. or equivalent in Engineering or Packaging Degree - No experience is required. What else we look for: Sterile barrier system packaging experience is strongly preferred. Medical device packaging design preferred. Experience in highly regulated industry. Knowledge of sterilization methods and design requirements for medical device packaging is preferred. Demonstrate a strong working knowledge of standardized package testing and good working knowledge of regulatory requirements, examples: ISO-11607, ASTM D4169, etc. Successful work experiences with different packaging materials such as Tyvek, HIPS, PETG, Polycarbonate, Polyolefins, or co-ex films as well as good knowledge of material forming processes such as thermoforming, injection molding, extrusion/extrusion blow, or FFS is desired ability to develop and execute protocols for packaging design, process validation and shelf-life studies; source, purchase and qualify equipment as well as develop and validate packaging processes. Good understanding of statistical techniques and proven expertise in usage of related statistical knowledge for packaging. CAD experience preferred. Solid technical writing skills and knowledge of documentation requirements. Must be able to work in a team environment, including the ability to manage vendors and project stakeholders. Ability to build productive internal/external working relationships. Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations. Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills. Strong problem-solving, organizational, analytical and critical thinking skills. Good leadership skills and ability to influence change. Ability to manage competing priorities in a fast-paced environment. 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 $103,000 to $146,000 (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. #J-18808-Ljbffr

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