Job Position: Medical Device Engineers/designers
Job Duration: 6+ Months
Job Location: Round Lake, IL
- Medical Device Engineers/designers with experience container development (IV fluid Saline solution & Medication bags, sterile packaging).
- The engineer will be designing a container (possibly a syringe) to house and deliver the new pharma therapy that is being developed by the chemist.
- The container has be FDA approved after it is designed, highly regulated and documented.
- BS in Engineering (CE, ME, IE, Bio M).
- 1 - 3 years medical device/products (bags) experience focused around validation of design and design remediation.
- Medical Device Product Development (Sterile packaging).
- Data Analysis Software: Minitab, Excel (pivot tables, v-lookups, etc), & DOORs
- Design verification, container integrity, and product requirements.
- Plastic containers for intravenous injections (ISO 15747:2010)
- Must have initial training in concepts of Six Sigma Quality techniques.
- Risk Assessment Categorization Tool (RACT) is designed to allow users to determine a risk mitigation plan for studies.