Title: Product Development Engineer

Location: Providence, RI

Duration: 6 months Contract

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
• Ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team

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