Design Engineer

4 weeks ago

Waukegan, United States The Fountain Group Full time
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
\r
Browse our website below for additional information on our company.\r
\r
The Fountain Group\r
\r
4505 Woodland Corporate Blvd, Tampa, FL 33614\r
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”

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