Research and Development Engineer 2

Cook Winston-Salem; Winston-Salem (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Cook (Winston-Salem) is seeking an experienced Research and Development Engineer 2 to join the engineering team in Winston-Salem, NC. You will lead technical development, drive design decisions, and ensure products meet clinical needs, safety, and quality standards.

You will collaborate with SMEs, physicians, and product managers to deliver innovative medical devices, maintain design history files, and contribute to IP generation while complying with regulatory requirements.

Qualifications

• Bachelor's degree in Engineering is required with 3 years of relevant experience; advanced degrees may reduce experience.
• Strong analytical and critical thinking skills are required.
• Excellent technical writing abilities and cross-functional collaboration skills are expected.
• Knowledge of ISO, FDA medical device standards is preferred.
• Fluency in AI and data concepts, with ability to evaluate AI outputs and communicate insights.

Responsibilities

• Lead technical development for portions of projects/programs.
• Support key design decisions to ensure quality of design selections for customer needs.
• Develop and maintain design history files and project documentation.
• Collaborate with SMEs, physicians, and product managers to develop medical devices.
• Provide technical input on IP generation and innovative problem solving.
• Work with cross functional teams to achieve project milestones and compliance.

Skills

Analytical thinking

Technical writing

Cross-functional collaboration

AI and data concepts

Regulatory standards (ISO/FDA)

Education

Bachelor's degree in Engineering

Job description

Research and Development Engineer 2

Job Location(s): Winston-Salem NC United States

Travel: Less than 10%

Position Type: Full Time

Company: Cook (Winston-Salem)

Category: Engineering

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 li">responsibility li">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

• 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.