Research and Development Engineer 2

Cook Group•Winston-Salem, NC

About The Position

The Research and Development Engineer 2 is a technical leader and/or growing subject matter expert who applies engineering principles to solve technical challenges and ensures products meet clinical needs, safety requirements, and quality standards. The role supports technical development and subject matter expertise across projects and programs, contributes to design decisions and best practices, and helps develop innovative medical devices and technologies. The engineer interprets data, organizes and coordinates project activities, develops and maintains design history files, contributes to new processes and solutions, and provides technical input related to company intellectual property. The role requires collaboration with cross-functional groups and compliance with Quality, Regulatory, and company policies and systems. Candidates must be legally authorized to work in the United States; the company does not intend to provide employment visa sponsorship.

Requirements

Bachelor’s degree in Engineering.
Three years of relevant experience; relevant Master’s or PhD degrees may reduce the experience requirement by 2–4 years.
Experience in a technical role within the medical device industry, a regulated industry, or an adjacent area.
Strong analytical and critical-thinking skills.
Strong technical-writing skills.
Ability to work with cross-functional teams to solve complex problems.
Fluency in artificial intelligence and data concepts, including critically evaluating AI outputs, improving workflows using approved tools, identifying and mitigating bias or inaccuracies, and communicating AI-driven insights clearly and responsibly.
Ability to perform the essential functions of the job, subject to applicable reasonable accommodations.
Legally authorized to be employed in the United States; employment visa sponsorship is not intended.

Nice To Haves

Knowledge of relevant ISO, EU, and FDA medical-device standards and regulations.

Responsibilities

Continue to perform the functions, duties, and expectations of the Research and Development Engineer 1 at a high level, as applicable.
Lead technical development for portions of projects or programs.
Support key design decisions to ensure design selections meet customer needs.
Attain goals within the area of expertise.
Work with project or program teams to identify and agree on focus areas across functional departments.
Conduct research and contribute to the development of best practices in focus areas.
Support and contribute to creating procedures or white paper guidance for functional groups.
Deploy knowledge and support the correct implementation of new concepts and approaches.
Interact with subject matter experts, physicians, and product managers to develop innovative medical devices that improve patient care, as applicable.
Interpret data and organize, execute, and coordinate project activities within portions of projects or programs.
Develop and execute activities and documentation to create and maintain design history files.
Assist with developing and implementing processes and solutions that affect achievement of department business metrics.
Use and implement engineering knowledge and technical expertise to support the department.
Provide technical input on company intellectual property relevant to the work area to drive innovation and intellectual property generation.
Use innovative and creative problem-solving techniques to develop and implement medical devices and technologies, address complex engineering challenges, and support product and process excellence.
Collaborate, communicate, and manage effective relationships with cross-functional groups to support project milestones.
Learn the organization’s business processes and systems as applicable to the role.
Comply with Quality, Regulatory, and company policies and systems.