Duration: 6 months Potential: Extension or conversion to full-time
Overview: Seeking an experienced Process Development Engineer with strong catheter manufacturing expertise to support process characterization, validation, and manufacturing support activities in a regulated medical device environment.
Key Responsibilities:
Develop, characterize, and optimize catheter manufacturing processes
Execute process characterization studies and data analysis (DOE, Minitab)
Support TMV / process validation activities (IQ/OQ/PQ)
Author and execute validation protocols and reports
Provide hands-on support for catheter manufacturing equipment
Partner with Manufacturing, Quality, and R&D to troubleshoot and improve processes
Qualifications:
Bachelor’s degree in Engineering or related field
5–7+ years of medical device process development or manufacturing experience
Strong catheter process and equipment experience
Proficient with Minitab and statistical analysis
Experience in GMP / regulated environments
