Assist with the creation of Quality documents in the support of New Product Development’s design transfer initiative. The scope of this role is to provide the student with an understanding of the requirements of the medical device design and development process. Additionally, through review of inspection plans and engineering drawings, the individual will gain knowledge of Class I medical devices and the regulatory requirements that govern the industry. The candidate must be able to work in collaboration with Quality Engineer, Manufacturing Engineering, Research and Development (R&D) and Document Control in a dynamic environment.
• Ability to read and translate engineering drawings
• Ability to maintain focus through varying priorities and ever changing requirements
• Ability to execute on deliverables as provided by the manager / supervisor
• Possess refined organizational scales, with an attention to detail and consistency
• Must demonstrate the ability to read process flow maps, dFMEAs and pFMEAs
• Currently enrolled in a college or university or, recent college graduate
• Working knowledge of MS Office (Outlook, Excel, and Word)
• Excellent organizational and interpersonal skills
• Reliable, flexible and professional
• Positive attitude with self-initiative
• Understanding of Geometric Dimensioning & Tolerancing (GD&T)
• Experience with inspection software
• Experience with SolidWorks (specifically, creating and designing holding fixtures)
Work Environment: While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles, moving mechanical parts and vibration. The noise level in the work environment varies, depending on location.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk, see and hear. Specific vision abilities required by this job include close vision while using a computer. Additionally, this position is typically stationery; spending several hours working at a desk This position also involves walking, bending, kneeling, stooping, crouching, going through file cabinets or moving archived boxes. The employee may need to lift or move boxes up to 40 lbs. Requires occasional travel between buildings.