Leader in medical device manufacturing is looking for a Product Development Engineer in Round Lake IL. This role will be responsible for representing the global risk management process in leading Risk file generation for legacy products (disposable devices and/or drug products). The individual in the position will be required to facilitate the collaboration of information from medical, R&D, quality engineering and maintain compliance to the quality system in order to generate a risk management file. The incumbent will perform other duties assigned as required to support the larger risk management goals and initiatives.This is a contract opportunity expected to last 12 months, could be longer based on performance, possible temp to perm. Currently we are only looking for local candidates. Great Contractor Benefits! Apply Now!
location: Round Lake, Illinois
job type: Contract
salary: $28 - 34 per hour
work hours: 9am to 5pm
1) Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
2) Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
3) Ability to manage routine small projects without assistance.
4) Investigate and analyze customer complaint data and design documentation.
1) Bachelor of Science in either Engineering or Science
2) 1 - 3 years recent, related experience in a regulated environment.
3) Experience with GDPs and GMPs
4) Experience with Design History File (DHF), strongly preferred.
5) Previous project coordination/management experience strongly preferred. Even candidates that have project engineering degrees and experience highly desirable.
6) Software: Excel (Pivot Tables, V-lookups, etc.)-required, PowerPoint, Outlook, Word, SharePoint
7) Nice to have Software: Trackwise 8, Minitab & DOORS
8) Previous compliant experience, nice to have
9) Soft skills: adaptable, resourceful, ability to follow up and knowledge of when to escalate.
skills: -Team Player
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.