Engineer (Combination Products) in North Chicago, IL

Contractor Engineer Combination Products

Description

• The Contractor Engineer Combination Products works under technical supervision on project teams in support of combination products and medical devices.
• Activities include contributing to product design documentation and conducting laboratory studies of product performance in support of product development, manufacturing transfers and investigations, supplier driven design changes, and product enhancements.
• 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.

Primary Function / Primary Goals / Objectives:

• Conduct independent laboratory work and data analysis with emphasis on mechanical testing
• Perform documentation analysis and prepare technical transfer documentation
• Create technical documentation for products in development
• Prepare design change documentation for existing products
• Design, develop and build experiment fixtures/jigs via engagement with vendors
• Troubleshoot experiments and instrumentation
• Learn and understand new experimental techniques
• Demonstrate skill in multiple techniques and modify protocols as required
• 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:

Level of Expertise:

• Proficient in technical transfers and design control principles for medical devices
• Proficient with documentation management systems
• Proficient with CAD, design principles, GDT and data management systems
• Proficient working in a laboratory environment with a focus on mechanical testing
• Experienced in rapid prototyping technologies and equipment
• Able to work in a regulated environment
• Familiar with lab environment, safety practices and Electronic Notebook handling.
• Familiar with tool room environment, metrology and CMM principles
• Applies basic computer skills in support of data analysis
• Applies technical writing skills to produce technical protocols, reports, and other documents

Level of Leadership Activities:

• Works under direction of senior staff
• Summarizes and presents results of projects to project teams
• Able to train other staff members on experiment methods, protocol procedures, manufacturing and prototyping techniques
• Independently 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

Qualifications

Basic:

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

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