Regulatory Test Engineer

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Regulatory Test Engineer for a 6 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

The engineer is responsible for the analysis and testing of product-representative materials for regulatory submissions, with a focus on writing protocols and technical reports in our client and their Ortho Advanced Technology Department.

Responsibilities

• Coordinate with internal and external collaborators, suppliers and vendors to generate product-representative samples and execute materials testing to support regulatory submissions. 
• May participate in lab activities.
• Generate technical memos and protocols/reports to a level of detail as required by the audience, up to and including that necessary to support a regulatory submission.
• Role focuses on metal/ceramic materials

Requirements

• A minimum of BS degree in Materials Science/Engineering, Biomedical Engineering, Mechanical Engineering, or similar field with emphasis on material analysis and testing.
• Prior experience writing scientific documents, such as protocols and technical reports.
• Demonstrated organization skills and attention to details, especially in writing and documentation.
• Experience conducting basic statistical analysis and familiarity with Minitab and/or MS Excel.
• Ability to coordinate activities of project team members.
• Basic understanding of mechanical and/or chemical testing of ceramics and/or metal biomaterials, such as tensile bond strength or X-ray diffraction, preferred.
• Demonstrated inter-personnel, verbal and written communication skills and the ability to work effectively both independently and on a team.
• Medical device or similar regulated industry experience preferred.
• Experience with manufacturing processes preferred.
• Preferred experience preparing technical reports for regulatory submissions, such as EU MDR or equivalent.