Previous Job
Previous
Engineer II
Ref No.: 18-13808
Location: Round Lake, Illinois
Position Type:Engg
Start Date / End Date: 10/01/2018 to 09/30/2019
Job Description:
 
Engineer II
 
Summary
 
This role will be responsible for representing the global risk management process in leading Risk file generation for legacy Baxter 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.
 
Responsibilities
 
  • Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
  • 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.
  • Ability to manage routine small projects without assistance.
  • Investigate and analyze customer complaint data and design documentation.
 
Qualifications
 
  • The individual must be proficient in working and generating documents in a GDP environment and a working knowledge of risk management (ISO 14971) or ability to quickly gain knowledge in this area.
  • Knowledge of the basic principles in various engineering disciplines.
  • Must have initial training in concepts of
  • Six Sigma
  • quality techniques.
  • Must know how to effectively run projects, coordinate contractors, and direct the activities of a technician
 
Education / Experience
 
  • Bachelor of Science in either Engineering or Science
  • 1 - 3 years recent, related experience in a regulated environment.
  • Experience with GDPs and GMPs
  • Experience with Design History File (DHF).
  • Software: Excel (Pivot Tables, V-lookups, etc.)-required, PowerPoint, Outlook, Word, SharePoint
  • Nice to have Software: Trackwise 8, Minitab & DOORS
  • Previous compliant experience, nice to have
 
Interview platform: may vary, but right now 1.5 hours onsite interview 30 minute individual with the report to manager followed by an hour panel interview with other team members.
 
Manager Note:
 
Key things to look for on resumes:
 
  • Previous project leadership experience/facilitator of decision making
  • Detailed, clear and concise written communication (how the resumes is presented will reflect this aptitude)
  • Previous experience with DHF. Contractors will be reviewing DHF files for FMEAs, Verification and validation reports and some design outputs to build risk files.
  • Previous experience with GDPs & GMPs, required
  • Previous manufacturing exposure, preferred
  • Previous compliant experience, nice to have
  • Bachelors of Science either in Engineering or Science discipline only
  • Excel (Pivot tables & V-lookups, etc.) and nice to have software. // Interview platform: may vary, but right now 1.5 hours onsite interview 30 minute individual with the report to manager followed by an hour panel interview with other team members.
Apply on-line for immediate consideration, please send your updated resume and contact info via
Contact: Asha Krishna
Email: asha@sunrisesys.com | 732-395-4591