Engineer III (Design Engineer) - US Tech Solutions, Inc.
North Chicago, IL 60064
About the Job
Description:
Top 3-5 skills, experience or education required
Design Control/Design History File, Test Method Validation and Transfer, Mechanical Design
Nice to have (but not required) skill
CAD, statistics
Description – Engineer III
• Perform documentation analysis and prepare technical transfer documentation
• Create technical documentation for products in development
• Prepare design change documentation for existing products
• Design and execute laboratory studies supporting product development and investigations
• Demonstrate skills in creating testing protocols and writing technical reports
• Troubleshoot experiments and instrumentation
• Learn and understand new experimental techniques
• Place data in proper scientific context by consulting and citing relevant literature
• Demonstrate technical proficiency in medical device performance characterization
• Understand and adhere to corporate standards regarding code of conduct, safety, medical device design controls and GxP compliance.
Major Responsibilities:
• Proficient in technical transfers and design control principles for medical devices
• Proficient with documentation management systems
• Able to work in a regulated environment
• Able working in a laboratory environment with a focus on electro-mechanical testing
• Familiar with CAD, design principles, GDT, tolerance stack analysis, tool room environment, metrology and CMM principles
• Familiar with lab environment, safety practices and Electronic Notebook handling
• Applies basic computer skills in support of data analysis
• Applies technical writing skills to produce technical reports and documents
Level of Leadership Activities:
• Works under direction of senior staff
• Summarizes and presents results of projects to project teams
• Independently performs design impact analysis and executes laboratory studies and proposes improvements to laboratory capabilities and processes
Level of Interpersonal Skill:
• Works in team environment
• Collaborates with others on design and data analysis
• Able to present work to small groups
Education:
• Bachelor’s Degree or equivalent education in Biomedical, Mechanical, Chemical Engineering, Materials Science or related field with 5+ years of experience
• Master’s Degree or equivalent education in Biomedical. Mechanical, Chemical Engineering, Materials Science or related field with 3+ years of experience
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Top 3-5 skills, experience or education required
Design Control/Design History File, Test Method Validation and Transfer, Mechanical Design
Nice to have (but not required) skill
CAD, statistics
Description – Engineer III
- The Contractor Engineer Combination Products works under technical supervision on project teams in support of combination products and medical devices.
- Activities include contributing to manufacturing transfers and investigations, supplier driven design changes and product enhancements, product design documentation and conducting laboratory studies of product performance in support of product development. Products are intended for drug delivery and include plastic disposable and implantable products, injection devices, and electromechanical devices with integrated software.
- Work is conducted in compliance with device design controls (FDA 21CFR820.30 and/or ISO 13485) as applicable.
- In addition, the position will have responsibility for developing product knowledge through initiatives involving understanding of existing on-market competitive products, materials research and computer simulations.
• Perform documentation analysis and prepare technical transfer documentation
• Create technical documentation for products in development
• Prepare design change documentation for existing products
• Design and execute laboratory studies supporting product development and investigations
• Demonstrate skills in creating testing protocols and writing technical reports
• Troubleshoot experiments and instrumentation
• Learn and understand new experimental techniques
• Place data in proper scientific context by consulting and citing relevant literature
• Demonstrate technical proficiency in medical device performance characterization
• Understand and adhere to corporate standards regarding code of conduct, safety, medical device design controls and GxP compliance.
Major Responsibilities:
• Proficient in technical transfers and design control principles for medical devices
• Proficient with documentation management systems
• Able to work in a regulated environment
• Able working in a laboratory environment with a focus on electro-mechanical testing
• Familiar with CAD, design principles, GDT, tolerance stack analysis, tool room environment, metrology and CMM principles
• Familiar with lab environment, safety practices and Electronic Notebook handling
• Applies basic computer skills in support of data analysis
• Applies technical writing skills to produce technical reports and documents
Level of Leadership Activities:
• Works under direction of senior staff
• Summarizes and presents results of projects to project teams
• Independently performs design impact analysis and executes laboratory studies and proposes improvements to laboratory capabilities and processes
Level of Interpersonal Skill:
• Works in team environment
• Collaborates with others on design and data analysis
• Able to present work to small groups
Education:
• Bachelor’s Degree or equivalent education in Biomedical, Mechanical, Chemical Engineering, Materials Science or related field with 5+ years of experience
• Master’s Degree or equivalent education in Biomedical. Mechanical, Chemical Engineering, Materials Science or related field with 3+ years of experience
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Source : US Tech Solutions, Inc.