Packaging/Sterilization Development Engineer-Leesburg, VA

K2M is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™. They are currently looking to hire a Packaging/Sterilization Development Engineer at our corporate headquarters in Leesburg, Virginia.
http://www.k2m.com/about-us/about-k2m/

Conducts engineering research and development activities on terminally sterile packaging systems. Supervises designers and technicians; guides and reviews their progress and evaluates / approves the results of their work. Personally contributes to development activity by providing original concept work overall and assisting in validating terminally sterile packaging systems. Manages small development projects, or selected portions of larger projects, under the supervision of a project engineer.

Essential Duties and Responsibilities include the following:
• Conceive, design and develop sterile packaging for novel spinal implants and instruments in accordance with established policies, goals, and objectives
• Assist the validation of new products and product concepts using existing and emerging technologies per design control requirements. This includes but is not limited to packaging, sterilization, shelf life, biocompatibility and cleaning validations.
• Perform component and assembly design and solid modeling using SolidWorks CAD software for packaging systems.
• Contribute to the development and authorization of SOPs, operational procedures, part and assembly drawings, test reports, MRB decisions, and other related documents.
• Participate in and lead, as applicable, design reviews.
• Prepare and review information for patent applications.
• Perform component and process vendor identification and support. Assist in the effort to verify and validate new packaging designs.
• Prepare test protocols and reports.
• Prepare support materials for regulatory submissions including 510(k), PMA, and CE mark.
• Work with Marketing and/or directly with customers; help ensure packaging design and testing of prototypes to meet market and customer requirements.
• Maintain sufficient and accurate technical records in an engineering notebook per company policies.
• Support material review board and corrective action requirements as they relate to R&D support and personnel.

Education/Experience:
Bachelor’s degree in Packaging, Packaging Science, Packaging Systems and Design, or related Engineering discipline preferred.

For a complete job description see: https://k2m.csod.com/ats/careersite/JobDetails.aspx?id=441