• 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