Overview

We are seeking a highly motivated and innovative Senior Research and Development (R&D) Engineer to join our dynamic team. In this pivotal role, you will lead cutting-edge projects focused on the development of advanced medical devices and medical technologies. Your expertise will drive the design, testing, and validation of new products, ensuring they meet rigorous regulatory standards and quality benchmarks. This position offers an exciting opportunity to contribute to transformative healthcare solutions through collaborative engineering, research, and scientific excellence.

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Responsibilities

Lead the design and development of medical devices, utilizing CAD software such as SolidWorks and other 3D modeling tools to create detailed mechanical designs for product prototypes.
Conduct comprehensive research in the latest technologies to incorporate in the development and testing in innovative product features and functionalities.
Manage project schedules, coordinate cross-functional teams, and oversee project management activities to ensure timely delivery of milestones.
Develop and execute experiments using design of experiments (DOE), assays, and laboratory techniques aligned with GMP (Good Manufacturing Practice) standards.
Perform mechanical engineering analyses including mechanical design validation, and engineering product development for medical device applications.
Analyze data from testing procedures, statistical analysis for research, and engineering validation to optimize device performance.
Ensure compliance with regulatory standards such as FDA regulations, ISO standards specific to medical device engineering in various locations, and legal requirements for medical device manufacturing.

Qualifications

Bachelor’s degree in Engineering and minimum of 7 years in medical device product development,
Proven experience in medical device design, testing, and manufacturing within regulated environments such as GMP or CGMP settings.
Strong proficiency in CAD software including SolidWorks or equivalent 3D modeling tools; familiarity with CAD software for product design is essential.
Skilled in project scheduling, project management methodologies, and cross-functional collaboration across R&D teams.
Knowledge of statistical analysis tools and data analysis skills for research validation purposes.
Familiarity with design controls, engineering validation processes, clinical trials procedures, and regulatory/legal compliance standards such as FDA regulations.
Excellent problem-solving skills with a focus on experimental design, technical proficiency in laboratory testing, and manufacturing processes.

Join us to be at the forefront of innovation in medical device development! Your expertise will help shape the future of medical devices that improve patient outcomes worldwide while working in a collaborative environment that values your contributions every step of the way.

Pay: $105,000.00 - $115,000.00 per year

Benefits:

Dental insurance
Health insurance

Work Location: In person

Prevailing Medical

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