Research and Development Engineer 2

Cook Group • Winston-Salem, NC

4d • Onsite

About The Position

The Research and Development Engineer 2 will be a technical leader and/or growing subject matter expert, applying engineering principles to solve technical challenges and ensuring products meet clinical needs, safety requirements, and quality standards. This role involves leading technical development for portions of projects/programs, supporting key design decisions, and attaining goals within their area of expertise. Additionally, the role requires contributing to the development of best practices, creating procedures or white paper guidance, and deploying knowledge to support the implementation of new concepts. Interaction with SMEs, physicians, and product managers is expected to develop innovative medical devices. The engineer will interpret data, organize and execute project activities, develop and maintain design history files, and assist with the development of new processes and solutions impacting department business metrics. They will utilize engineering knowledge to support the department, provide technical input on intellectual property, and employ creative problem-solving techniques for cutting-edge medical devices. Collaboration with cross-functional groups is essential for achieving project milestones. The role also includes learning organizational business processes and systems, and complying with quality, regulatory, and company policies.

Requirements

• Bachelor’s degree in Engineering and 3 years’ relevant experience required.
• Relevant advanced degrees (Master’s or PhD) may reduce the experience requirement by 2-4 years.
• Experience in a technical role within Medical Device or regulated industry/adjacent experience.
• Strong analytical and critical thinking skills.
• Strong technical writing.
• Ability to work with cross functional teams to solve complex problems.
• Fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers.
• Qualified candidates must be legally authorized to be employed in the United States.
• Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.

Nice To Haves

• Knowledge of relevant ISO, EU, FDA medical devices standards regulations is preferred.

Responsibilities

• Continue to perform the functions, duties, and expectations of the Research and Development Engineer 1 at a high level, as applicable.
• Leading technical development for portions of projects/programs.
• Support key design decisions to ensure quality of design selection to meet customer needs.
• Attainment of goals within area of expertise.
• Work within project/program team(s) to identify and agree on focus area(s) for their projects across the functional department(s).
• Conduct research and contribute to the development of best practices in focus area(s).
• Support and contribute to the creation of procedures or white paper guidance for functional groups.
• Deploy knowledge and support the correct implementation of new concepts and/or approaches.
• Interact with SME’s, physicians, and product managers to develop innovative medical devices to improve patient care, as applicable.
• Assumes responsibility in interpreting data, organizing, executing, and coordinating project activities within portions of projects/programs.
• Develop and execute activities and documentation to create and maintain design history files.
• Assists with the development and implementation of new processes and solutions that will impact the achievement of the department business metrics.
• Utilize and implement engineering knowledge and technical expertise to support the department.
• Provide technical input on company intellectual property relevant to area of work to drive innovation and IP generation.
• Assist with innovative and creative problem-solving techniques to develop and implement cutting edge medical devices and technologies, overcoming complex engineering challenges and driving product/process excellence to support projects/programs within the department.
• Collaborate, communicate, and manage effective relationships with cross functional groups to support the achievement of project milestones.
• Learn the organization’s business processes and systems, as applicable to your duties and responsibilities.
• Comply with Quality, Regulatory, and company policies and systems.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level