Design and validate manufacturing processes, equipment, and fixtures for catheter production. Support scale-up efforts from development to commercialization, including process validation and transfer.
Numbers & Facts
Location
Menlo Park, CA
Description
Qualifications:
Bachelors degree in engineering or related field
Experience of at least 8 years in medical device manufacturing
ISO 13485 and FDA environment
Ability to perform root cause analysis and execute process validations (IQ, OQ, PQ)
Understanding of statistical analysis (SPC, CPK, DOE)
Skilled in equipment, tooling, and fixture design, testing, and implementation
Knowledge of design tools, prototyping techniques, and process evaluation methods
Strong analytical skills and decision-making ability
Responsibilities:
Design and validate manufacturing processes, equipment, and fixtures for catheter production
Troubleshoot production issues and implement improvements for operational efficiency
Lead projects to enhance production metrics such as uptime, cycle time, and throughput
Collaborate with vendors to select and develop equipment suitable for manufacturing needs
Support scale-up efforts from development to commercialization, including process validation and transfer