Job Details
Job Description
Job Description
Pay: $55.00 to 59.00
Length: 1 year contract (potential for temp to perm)
Onsite Does have potential for hybrid schedule but based on workload.
Manager s desired skills:
- Design experience with CAD and GDT.
- Experience in lab environment.
- Safety practice and scientific documentation experience.
- Technical writing skills
- Develop, troubleshoot, and perform experiments with technical instrumentation.
- Medical Device/Combination Products experience
- Experience working in a regulated environment
- Bachelor s Degree or equivalent education in Biomedical, Mechanical, Chemical Engineering, Materials
Job Description
Will work 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
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
Company Description
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.
Browse our website below for additional information on our company.
The Fountain Group
4505 Woodland Corporate Blvd, Tampa, FL 33614
We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.
Company Description
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.\r\n\r\nBrowse our website below for additional information on our company.\r\n\r\nThe Fountain Group\r\n\r\n4505 Woodland Corporate Blvd, Tampa, FL 33614\r\n We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.