Clinical R&D Engineer

Job Requirements

At Quest Global, it’s not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.

Key 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.

We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every industry we reach. Our teams regularly invest time and dedicated effort into internal culture work, ensuring that all voices are heard.

We wholeheartedly believe in the diversity of thought that comes with fostering a culture rooted in respect, where everyone belongs, is valued, and feels inspired to share their ideas. We know embracing our unique differences makes us better, and that solving the worlds hardest engineering problems requires diverse ideas, perspectives, and backgrounds. We shine the brightest when we tap into the many dimensions that thrive across over 21,000 difference-makers in our workplace.

Work Experience

Qualifications

• 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.