at Spectraforce Technologies Inc. in WaukeganNorth Chicago, Illinois, United States
Job Description
Title: Engineer
Location: North Chicago, IL 60064 (Hybrid based on workload)
Duration: 12 Months (Potential temp to hire)
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
* 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
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.
