Develops and validates manufacturing processes for complex medical-device catheters. Responsibilities include designing process parameters, tooling, fixtures, and semi-automated equipment; conducting DOE and statistical process studies; executing IQ/OQ/PQ validation; leading product introductions and process improvements; preparing engineering documentation; supporting quality investigations; and mentoring engineers.

The Senior Staff Process Development Engineer oversees manufacturing line design, capacity analysis, and process validation while leading cross-site initiatives and mentoring junior engineers.