Description

POSITION DESCRIPTION

Position Title: Intern, R&D Program Management

Reports To: Program Management Director

Department: Program Management

FLSA Status: Non-Exempt

Scope of Role: Intern

Version Date: 2024.02.12

Job Code: InternProgMgmt

Job Grade: TBD

PURPOSE OF POSITION

This is a non-remote paid internship offering full-time hours working in the R&D Program Management department for an in vitro diagnostic Point of Care (POC) system during the summer months. This intern position will work closely with engineering and all departments across the company to ensure FDA design controls are followed and documented properly for new products and engineering changes on exiting products. All interns are required to conclude the program by giving a formal presentation on their work.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

Under the direction of Manager:

• Manage Design and Development Plans and active work for Active Projects including, but not limited to, Military Authorization to Operate Certification and active New Product Development Projects.
• Participate in continued project management improvements in R&D specifically around portfolio management and reporting.
• Support active project management support for other departments looking to apply Project Management principles in their department.
• Work closely with engineering and all departments across the company to ensure FDA design controls are followed and documented properly for new products and engineering changes.
• Support small exploratory engineering projects currently in the Project Screening Phase.
• Give a formal presentation on their work at the conclusion of the internship period.

Requirements

KEY COMPETENCIES

• Strong people skills.
• Attention to detail.
• Experience with MS Suite (Word, PowerPoint, Excel).
• Must have a cell phone that can be used for work.

EDUCATION & EXPERIENCE REQUIREMENTS

Some combination of the following educational background(s) is preferred:

• Undergraduate rising seniors pursuing a 3-month internship with the following declared majors: Biomedical Engineering, Industrial (and/or Systems) Engineering, Mechanical Engineering, or Computer Science/Engineering.
• Graduate students pursuing a Master of Engineering Management (or similar) degree.
• Graduate students pursuing an MBA with an undergraduate degree in engineering.
• Exceptional rising engineering juniors (especially biomedical) with design controls experience may be considered.

Minimal experience is required for this position. With that in mind, the desired work experience (or evidence of those desires through previous non-work-related experiences in lieu of actual work experience) is listed below.

• Experience (or demonstrated desire to gain experience) in one or more of the following areas:
• The medical device industry.
• Managing projects through FDA compliant design controls (academic experience with design controls also greatly beneficial).
• Design transfer into manufacturing/operations.
• Improving or working within a product development portfolio review process.

PHYSICAL AND COGNITIVE DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• This position is primarily based out of the company Headquarters in Durham, NC.

While performing the duties of this job, the employee is regularly required to:

• Complete all company required training that is specified for the role, as defined by our compliance and training processes and protocols, which may be job specific or corporate/compliance related.
• Listen and communicate using both verbal and written feedback. Must be able to exchange accurate information in these situations.
• Maintain a high level of consistent cognitive function.
• Perform consistent keyboarding/computer use in a typical office environment for extended periods of time, up to 8 hours per day.
• Frequently move about the office.
• Stoop, kneel or crouch when maneuvering the office environment.
• Perform work in manufacturing and/or scientific laboratory environments for extended periods of time, up to 8 hours per day.
• Lift up 50lbs at times. 
• Be fully vaccinated against Covid-19 or meet the requirements for a medical or religious exemption.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions and perform any other duties, as assigned by their manager.