Sr Process Engineer

Responsibilities :

Design, develop, and optimize processes for the manufacturing of medical devices, such as injection molding, extrusion, assembly, packaging, sterilization, etc.

Conduct process characterization, design of experiments (DOE), risk assessment, and statistical analysis to identify and control critical process parameters and sources of variation.

Write and review process development documents, such as process flow diagrams, process specifications, process failure mode and effects analysis (PFMEA), etc.

Perform process validation activities, such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), in accordance with regulatory requirements and industry standards.

Develop master validation plans (MVPs) for equipment and processes, ensuring alignment with project objectives and timelines.

Troubleshoot and resolve process issues during development and manufacturing activities.

Provide technical guidance and training to junior process development engineers and technicians.

Maintain current knowledge of process development and validation best practices, regulatory requirements, and industry standards.

Support product development and transfer projects by working closely with cross-functional teams, such as engineering, quality, manufacturing, and regulatory affairs.

Demonstrate good manufacturing practices (GMP) related experience of execution and documentation of process development and validation activities, such as MVPs, DOEs, PFMEAs, IQ, OQ, PQ, test method validations (TMVs), etc.

Evaluate and implement changes to processes based on development and validation results, feedback, or improvement opportunities.