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Packaging R&D Engineer II - Advanced Technologies

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: November 26, 2022

Job Description:

This position has a New Product Development focus and will provide overall package engineering support for new product development teams. Prototype, design, develop and validate packaging systems to primarily support clinical trials, limited market releases and commercial product launches. Specifically, the incumbent will provide R&D package engineering & 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 onFunctional Excellence and Value Expansion to develop world-class capabilities and provide a competitive advantage to Edwards.Key Responsibilities:- Develop and execute protocols for packaging design, process validation and shelf-life studies- 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.- Support new packaging technologies and strategies to improve time to market- Work through continuous changes, resulting from a dynamic product development environment, to translate the device changes into the package development process by working closely and continuously with cross-functional team membersand outside suppliers of materials and services- Source, purchase, install and qualify equipment as well as develop and validate packaging processesQualifications:- A Bachelor's degree is required, preferably in Package Engineering, but will consider a relevant scientific or engineering degree. The Packaging Engineer II requires a minimum two years of experience in package engineering.Master's Degree or equivalent in + internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/educationExperience 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 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 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 Polyolefins, 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 packaging design, process validation and shelf life studies; source, purchase,install and qualify equipment as well as develop and validate packaging processes- 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 to quickly assess design input requirements and translate into design outputs and eventually into a fully transferable package design and process to support speed to marketAdditional Skills:--- Good computer skills in usage of MS Office Suite; CAD experience preferred--- Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills--- Basic understanding of statistical techniques--- Previous experience working with lab/industrial equipment required--- Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering--- Solid problem-solving, organizational, analytical and critical thinking skills--- Solid understanding of processes and equipment used in assigned work--- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing--- Strict attention to detail--- Ability to interact professionally with all organizational levels--- Ability to manage competing priorities in a fast paced environment--- 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--- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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 -Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. - As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. - If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated. -

Keywords: Edwards Lifesciences Gruppe, Irvine , Packaging R&D Engineer II - Advanced Technologies, Engineering , Irvine, California

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