Automated Systems, Inc.

Deerfield, IL

Quality Engineer

$50,000-$107,500 / YEAR
Engineer III (Sr. Engineer)
Department: Quality
Medical Device: Surgical Tool (Class III)
1 year contract

Summary
Medical device remediation related project responsible for
designing, developing, implementing and evaluating optimal,
cost-effective projects and technologies.

Responsibilities:
1. Must have experience or advanced training and demonstrate
proficiency (e.g. Investigations, problem solving, total quality
management, statistical methods, DHF remediation, Risk file remediation,
problem analysis and resolution, materials science, design of
experiments etc.)
2. Good understanding of MDR remediation; extensive cross-functional
team experience, including technical and non-technical work.
3. Completely proficient in relevant products or process development processes.
4. Ability to organize and present technical and project management. overviews without assistance.
5. Act independently with minimal supervision to conduct smaller
approved projects. Expected to make suggestion on improvements based on
recent technical knowledge.
6. 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.
7. Ability to manage routine small projects without assistance.
8. Investigate and analyze customer service problems and design improvement suggestions. Recommend design improvements.


Requirements

Qualifications:
1) Knowledge of the basic principles in various engineering disciplines.
2) Must have initial training in concepts of
?Six Sigma
? quality techniques.
3) Must know how to effectively run projects, coordinate contractors, and direct the activities of a technician

Education/Experience:
BS in Engineering (discipline: Mechanical, Biomedical)
3-5 years of experience in Medical Device Product Development (NPD),
design control or change controls, DHF remediation, and product risk
files. Medical device related to Bio surgical products (experience with
Class II & III).
Software: Word, Excel, Visio, PowerPoint, Outlook
Nice to haves: CAPA and Change control Trackwise8 system experience
Preferences: good communication skills written and spoken

Job RequirementsQualifications: 1) Knowledge of the basic principles in various engineering disciplines. 2) Must have initial training in concepts of ?Six Sigma ? quality techniques. 3) Must know how to effectively run projects, coordinate contractors, and direct the activities of a technician Education/Experience: BS in Engineering (discipline: Mechanical, Biomedical) 3-5 years of experience in Medical Device Product Development (NPD), design control or change controls, DHF remediation, and product risk files. Medical device related to Bio surgical products (experience with Class II & III). Software: Word, Excel, Visio, PowerPoint, Outlook Nice to haves: CAPA and Change control Trackwise8 system experience Preferences: good communication skills written and spoken