Process Development Engineer

• Author and execute Process Validations including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ)


• Responsible for process development, equipment specification, acquisition and implementation.


• Understands engineering principles theories, concepts, practices and techniques.


• Analyzes and solves problems from basic engineering principles.


• Completes design of experiments, validation, completion of testing and analysis of data for continuous improvement activities. Presents data to equipment teams.


• Suggests and supports new methods or materials for continual improvement of quality and efficiency.


• Analyzes current equipment for process suitability and provides detailed plans for improvement


• Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe procedures


• Works with other engineers and technicians in developing solutions and improvements in materials, equipment and process as necessary


• Participates in teams as necessary to ensure continual improvement, safety and compliance


• Provides training and process expertise for product processing in specific areas such as process development, tooling development and validation.


• Interacts cross functionally and with internal and external customers.

• Previous experience in Process Development at a medical device company


• Process Validation experience - TMV/IMV, IQ, OQ, PQ


• Self-driven and can own multiple aspects of a project at a time


• Equipment development, documentation, and validation


• Problem solving skills and statistical analysis.

Pay Range:

• $50-55/Hr