Validation R&D Engineer

About the Role

This is a 12+ month contract position located in California or Minnesota, focused on clinical R&D within the medical device sector, adhering to FDA guidelines and processes.

Requirements

• Bachelor’s degree in biomedical, mechanical, electrical, biological, or physical science.
• Minimum of 6 years of relevant work experience in medical product development, or an equivalent combination of a graduate degree with relevant project experience.
• Software release experience.
• Experience with FDA guidelines and processes, particularly in a clinical R&D or medical device context.
• Heavy experience with clinical guidelines.

Responsibilities

• Investigate and define clinical requirements for new product/feature development and facilitate translation into new projects through clinical review and evaluation.
• Work with field and medical personnel to define benchmarks for evaluating the clinical performance of products/features.
• Simulate or test aspects of new projects to evaluate prototypes and validate output as meeting customer’s intended use requirements; analyze data collected from the field or research studies.
• Develop and direct preclinical evaluation protocols, data analysis, and reports.
• Contribute to the evaluation and validation of specific systems or projects for feasibility studies, usability and human factors analyses, technology assessments, concept studies, benchmarking studies, or submission studies.
• Provide input to the risk management file and Clinical Evaluation Reports in support of the product throughout its lifecycle.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Perform other related duties and responsibilities as assigned.

Skills

• Demonstrated ability to apply understanding of clinical application to resolve issues within assigned projects.
• Demonstrated ability to effectively integrate information from varied disciplines including Clinical Affairs, Engineering, Marketing, and Regulatory Affairs.