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Medical Device Engineer

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Job Details
Job Order Number
6918564
Company Name
Rose International Inc.
Physical Address
IL, Lake Forest
Lake Forest, IL 60045
Job Description

Client Position Title: Validation Engineer

Position Number: 327007

Location: Lake Forest, IL 60045

Desired Skill Set:

Medical device, Validation, Reporting, Data Analysis

Position Description:

C2C is not available

Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.
Work Location: Lake Forest – IL
Job Title: Engineering – Validation Engineer II
Duration: 18 months with possible extension

Role Description
• This role has primary responsibility for confirmation that medical devices and combination products meet their intended function.
• This includes development of data through engineering studies that informs new product development as well as test reports that support product submissions.
• The candidate will work within a team environment to solve problems and utilize best engineering practices and techniques for root cause and statistical analysis.
• This work entails defining test methods, developing protocols, performing data analysis, and writing reports in compliance with corporate procedures.

Responsibilities
• Partner with Systems engineers in defining product requirements such that they are verifiable
• Development of test fixtures, test methods, and performance of Test Method Validation activities
• Coordinate with internal and external partners and suppliers to procure test samples and manage conditioning and accelerated aging studies
• Ensure integrity and compliance of data according to Standard Operating Procedures
• Develop Verification Plans including test strategy
• Utilize technical writing and statistical data analysis skills to write protocols and reports
• As necessary, conduct root cause analysis and derive recommendations based on analysis of data
• Translate inspections and tests methods into component and product specifications

Qualifications
B.S. in Engineering with some medical device industry experience.
Familiarity with ISO standard test methods and related test instrumentation preferred.
Excellent analytical and communication skills required.
Ability to work and solve problems in team environment.
Technical writing skills are required for protocol and report writing.

PHYSICAL/MENTAL REQUIREMENTS
Physical requirements include walking, standing, and performing analysis including protocol and report writing. Includes hands-on test method development.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)


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