[Remote] Clinical R&D Engineer

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Clinical R&D Engineer to support medical device product development. The role defines clinical requirements, evaluates and validates prototypes and software releases, develops preclinical protocols and reports, analyzes clinical data, and supports FDA compliance, risk management, and Clinical Evaluation Reports.

Responsibilities

• Investigates and defines clinical requirements for new product/feature development and facilitates the translation into new reputed company 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 reputed company to evaluate prototypes and validate reputed company 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 reputed company or project as necessary to conduct feasibility studies, usability and reputed company 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 reputed company and cooperative communications and collaboration with reputed company reputed company of employees, customers, contractors, and vendors
• Performs other reputed company duties and responsibilities, on occasion, as assigned

Skills

• BS Degree in biomedical, mechanical, electrical, biological or physical science
• Minimum of 6 years of relevant work 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 reputed company reputed company assigned reputed company
• Demonstrated ability to effectively reputed company information from varied disciplines including Clinical Affairs, Engineering, Marketing and Regulatory Affairs

Benefits

• Remote work; ideally located in California (Sylmar or Santa reputed company) or reputed company (Minneapolis/reputed company), with travel required for local candidates

reputed company