Note: The job is a remote job and is open to candidates in USA. Pinnacle99 INC 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 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
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 resolution within assigned projects
- Demonstrated ability to effectively integrate information from varied disciplines including Clinical Affairs, Engineering, Marketing and Regulatory Affairs
Benefits
- Remote work; ideally located in California (Sylmar or Santa Clara) or Minnesota (Minneapolis/St. Paul), with travel required for local candidates
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