Company Type
Medical Device Manufacturer
Location
Palo Alto, California
Job Description
- Work with R&D to develop standard process platforms to support new market and product opportunities.
- Establish process capabilities for existing and new processes. Enhance capabilities if necessary.
- Optimize and Scales-up manufacturing process for new products in a timely manner.
- Perform Equipment Installation qualification (IQ) and process validation that includes operational qualification (OQ) and performance qualification (PQ).
- Establish and implement design for manufacturability standards to ensure compliance of product design to best manufacturing practices.
- Mentor other engineers on manufacturing development practices.
- Works with management teams to develop, define, and improve functional systems, procedures, and general policies.
Job Skills
- Three or more years of experience in an industrial or medical manufacturing environment, performing process development/engineering.
- Three or more years of hands on experience in extruding close tolerance medical tubing including single and multi-lumen products..
- Experience with GMP/QST/ISO guidelines a plus
- Bachelor’s Degree in Chemical, Mechanical or Plastics Engineering.
- Experience in plastic processing, Polymeric Co-Extrusion
- Experience within medical device manufacturing in support of FDA regulations preferred
- Experience in plastic expansion desirable
- Proficient in MiniTab or other statistics software program.
- Knowledge of processing of materials such as LDPE, HDPE, PTFE, FEP, PEEK or PVDF is very desirable.
Job ID: 4822
