Senior Manufacturing Engineer

12 Months contract

The Senior Manufacturing Engineer serves as the technical process owner responsible for manufacturing process validations, performance, equipment readiness, capacity expansion, and continuous improvement activities to meet the yield, capacity, throughput, reliability and quality goals. This role drives the development, validation, implementation, and optimization of manufacturing processes to ensure product quality, regulatory compliance, operational excellence, and successful commercialization.

• Develops and maintains manufacturing process specifications, work instructions, and engineering documentation

• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

• Develop and execute equipment and process validation activities, including IQ, OQ, and PQ protocols and test method development and validation

• Supports automation initiatives and advanced manufacturing technologies

Bachelors or Master or high degree and Experience supporting medical device manufacturing operations. Strong understanding of manufacturing process validation and equipment qualification. Experience with statistical analysis and process control methodology.