Engineer III (Combination Products)

Duration : 12 months contract

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Job 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.

Responsibilities : Level of Expertise :

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

Experience :

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.

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, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details : Name : Rudra

Name : Rudra

Email : [email protected]

Internal Id : 24-20356