Position Title: R&D Engineer
Work Location: Minnetonka MN
Assignment Duration: 5+ Months
1-3 years experience
Preferred education: Bachelor's degree
Required experience: Medical device
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.
