[Hiring] Clinical R&D Engineer @Sunrise Systems

Role Description

The Clinical R&D Engineer will be responsible for investigating and defining clinical requirements for new product/feature development and facilitating the translation into new projects through clinical review and evaluation.

• Works with field and medical personnel to define the benchmarks for evaluating the clinical performance of these products/features.
• Simulates or tests aspects of new projects to evaluate prototypes and validate output as meeting customers' intended use requirements; analyzes data collected from the field or from research studies.
• Develops and directs preclinical evaluation protocols, data analysis, and reports.
• Contributes to the evaluation and validation of a specific system or project as necessary to conduct feasibility studies, usability and human factors analyses, technology assessments, concept studies, benchmarking studies, or submission studies.
• Provides input to the risk management file and Clinical Evaluation Reports in support of the product throughout its lifecycle.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications

• BS Degree in biomedical, mechanical, electrical, biological or physical science.
• Minimum of 6 years of relevant work experience in medical product development and/or an equivalent combination of a graduate degree with relevant project experience.
• Demonstrated ability to apply understanding of clinical application to issues in order to bring tasks to resolution within assigned projects.
• Demonstrated ability to effectively integrate information from varied disciplines including Clinical Affairs, Engineering, Marketing and Regulatory Affairs.

Benefits

• Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees.
• We also offer Sick time benefits as required per State regulations.

Company Description