Scientist II

Overview

About Us:

Cordis is an independent, customer-focused global provider of interventional cardiovascular medical technologies. During our 60+ year history we've established a legacy of pioneering breakthrough technologies, including the first guiding catheters and coronary drug eluting stents. Cordis has built a strong global footprint that spans over 70 countries.

We're teammates, not just employees. Our culture empowers you to act like an owner and unleash your full potential in the process. With diverse teams on a global scale, we foster an inclusive atmosphere where everyone is embraced for who they are, their unique perspective, and what they bring to the table. We believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.

If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then Cordis is just the place for you. Join us, and let's improve the wellbeing of millions, together.

The Sterility Assurance Scientist II will report into the Sterility Assurance Organization. This position requires experience in sterility assurance with experience with different sterilization modalities such as Ethylene Oxide, Gamma, and E-Beam as well as industrial microbiology and analytical chemistry. The incumbent must have excellent communication, presentation and technical writing skills and be able to write technical protocol and reports and be proficient and knowledgeable with both the US and International sterilization, microbiology and analytical regulations and standards.

Responsibilities

Includes the following. Other duties may be assigned depending on the needs of the business.

• Responsible for writing, reviewing, approving technical protocols and reports, planning, and executing sterilization validations, annual reviews of sterilizers, support dose setting, dose audits and dose mapping projects and coordinate and executing Natural Product Resistance Testing
• Provide sterilization, microbiology, and analytical chemistry technical support to project engineering teams
• May at times perform microbiology and analytical testing.
• May serve as subject matter expert on sterility assurance product evaluation team and provide technical input with respect to the impact on product changes, sterilization nonconformances and/or lab deviations.
• May at times assist with coordinating microbiology and analytical laboratory testing.
• Develops, support and executes supplier quality agreements, supplier process specifications.
• Prepares and presents lab and sterilizer lab metrics.
• Must be able to lead technical projects
• Practices company safety and quality policies and procedures.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• May have an active participation in industry meetings such as AAMI and ISO May present at industry meeting, forums and seminars
• Executes complex assignments designed to continue the development of professional work knowledge and abilities requiring enhanced application of standard statistical techniques.
• May assist with regulatory audit and assist with technical audits at contract sterilizers or labs.
• May assist with gap assessment for Implementation of new or revised sterilization standards

Qualifications

A bachelor's in biology, industrial microbiology, chemistry, biomedical sciences, sterility assurance or science, with at least 8 years of related experience and/or training, or master's degree and 6 or more years of experience and/or training. Experience in industrial sterilization, microbiology and analytical chemistry is required.

Knowledge of process excellence, process improvement and risk analysis tools will be an asset. Must be proficient in Microsoft Word, Microsoft Project, Excel, and PowerPoint and Visio. Must be experienced with developing spreadsheet models, relational databases, and presentations. Ability to effectively solve complex problems and ability to influence and communicate across all functional groups and levels is a requirement. Must be able to support multiple projects and experienced in driving results by influencing others in a highly cross-functional environment with new product development, manufacturing, quality and sourcing. Must have knowledge of GMP, QSR, ISO Standards, must have experience working with implantable medical device. The position may require a combination of being onsite and remote. Bi-lingual is an added asset.