We are looking for Medical Device - Sr. Packaging Engineer for our client in Irvine, CA
Job Title: Medical Device - Sr. Packaging Engineer
Job Location: Irvine, CA
Job Type: Contract – 12 Months / Contract to Hire / Direct Hire
“US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time.”
- This position has a New Product Development focus and will provide overall package engineeringsupport for new product development teams.
- Will prototype, design, develop and validate packaging systems to primarily supportclinical trials, limited market releases and full scale 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 on Functional Excellence and Value Expansion to develop world-class capabilities and provide a competitive advantage.
Sr. Packaging Engineer Duties:
- 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.
- Validating packaging equipment and packaging manufacturing processes.
- Source, purchase, install and validate equipment as well as develop and validate packaging processes.
Sr. Packaging Engineer Requirements:
- A minimum of ten years (10) experience in package engineering.
- A Bachelor's degree is required, preferably in Package Engineering, but will consider a relevant scientific or engineeringdegree.
- A Master's degree in Business Administration or Package Engineering, Engineering, or related science/technical degree field is preferred.
- Experience in a medical device, biotechnology or a pharmaceutical environment is preferred but required.
- Experience in an FDA regulated industry, preferably medical device is optimal.
- Detailed knowledge of methods of sterilization and design requirements for medical device packaging – irradiation (Gamma or E-beam), or EtO, or Steam (Autoclave) is also required for the Principal Packaging Engineer level.
- Must have expert knowledge of Design Control and Risk Management, ISO, AAMI, EN868 and ASTM industry standards as well as domestic and international regulatory and government requirements and regulatory path - FDA, or KEMA, or TUV, or TGA is required for the Principal Packaging Engineer and Distinguished Packaging Engineer levels.
- 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 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.