Research and Development Engineer 2

americas-cookmedical; Winston-Salem (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

Cook Medical is seeking a Research and Development Engineer 2 in Winston-Salem, NC. The role focuses on applying engineering principles to create medical devices that meet clinical needs and safety standards.

You will lead portions of projects, interact with SMEs, physicians, and product managers, and help develop best practices and design history documentation. Qualifications include a Bachelor’s degree in Engineering and at least 3 years of relevant experience.

Qualifications

• Bachelor’s degree in Engineering and 3 years’ relevant experience required.
• Knowledge of ISO, EU and FDA medical devices standards regulations preferred.
• Fluency in AI and data concepts with ability to evaluate AI outputs and improve workflows.

Responsibilities

• Lead technical development for portions of projects/programs.
• Provide SME input and contribute to design decisions to meet customer needs.
• Develop design history files and support new processes and solutions.
• Collaborate with cross-functional teams including physicians and product managers.
• Communicate effectively to drive project milestones and technical excellence.

Skills

Analytical thinking

Technical writing

Cross-functional collaboration

AI fluency

Education

Bachelor’s degree in Engineering

Job description

Overview

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.

Responsibilities

• Continue to perform the functions, duties, and expectations of the Research and Development Engineer 1 at a high level, as applicable.
• Responsibilities for supporting technical leadership may include:
• 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.
• Responsibilities for providing subject matter expertise may include:
• 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.

Qualifications

Education and/or Work Experience Qualifications

• 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.

Knowledge and Skills and/or Abilities

• Strong analytical and critical thinking skills.
• Strong technical writing.
• Ability to work with cross functional teams to solve complex problems.
• Knowledge of relevant ISO, EU, FDA medical devices standards regulations is preferred.
• This role requires 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.

Physical Requirements

Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements, as applicable by country, of: (i) the ADA (Americans with Disabilities Act) (USA Only); (ii) Disability Discrimination Act 1992 (Australia Only); or (iii) other applicable local, regional, or national law or regulation.

• Work under general office environmental conditions
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.,
• In line with local health and safety requirements, personal protective equipment may be required in areas associated with this position.
• May require occasional travel.

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.

“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.” Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.