Product Development Engineer

We have a new position for a 12 month+ contract in RI. We need someone with a phamra or med device background.

The key to job and they MUST have experience with:

CCI and USP 1207

CCI stands for Container Closure Integrity (TESTING)

Most folks that worked in Pharma Injection Molding environments should have this experience.

Here is the JD but make sure should have the above CCI experience.

Job Profile Summary

The Product Development Engineer will be responsible for offering a high level of technical contribution to product development and optimization for ongoing and future projects. This role will contribute to the commercialization of novel combination-product technologies.
Immediate contributions can be made by a candidate with the following experience:
Knowledge in packaging of medical devices, packaging and shipping combination product in "cold" conditions
Different methods of producing sterile medical products such as terminal sterilization and aseptic processing techniques
Thorough knowledge of the Design Control process (e.g. waterfall model)
Capturing user needs and design inputs and understanding/ability to execute corresponding Design verification and validation activities (e.g. feasibility testing, protocol development, and technical report writing)
Working in controlled environments (e.g. Laboratory, cleanrooms, biosafety cabinets, etc.)
Working in a GxP environment
Working under FDA 21CFR part 820 regulations

Key Duties and Responsibilities:
Effectively collaborates with a fully integrated team to facilitate the success of projects
Applies fundamental scientific and engineering principles to process design, development, and process understanding.
Applies statistical principles to guide process optimization
Strong technical writing, authoring and reviewing protocols and reports.
Interacting regularly with outside vendors, and work effectively with cross functional teams within the same site, and across multiple sites.

Knowledge and Skills:
Excellent communication skills to explain complex technical/scientific information to others

Education and Experience:
Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related field is required.
Typically requires a Bachelor's degree with at least 5 years of experience or a Master's degree and at least 3 years of experience, or the equivalent combination of education and experience

Best Regards,

Satish J | IT Minds LLC

Direct: 949.561.0655, |Email: satish.j@itminds.net