Title- Materials Engineer

Location- Bloomington, IN(Onsite)

Overview

The Materials Engineer is responsible for working collaboratively with material scientists, biocompatibility specialists, regulatory scientists, toxicologists, engineers, project management, and internal and external stakeholders to develop regulatory submission documents that contain proper material information. This position will ensure the Cook organization is compliant to applicable regulatory requirements including both material regulations as well as biostability standards. This position will support the development of a material program that issues corporate level policies and procedures to standardize the management of material information. This position will improve the material evaluation process by establishing new criteria for databases, information systems, and training programs. This position will provide technical leadership to engineers and internal and external stakeholders to ensure the material selection is appropriate for both regulatory and design requirements for existing products as well as new product development.

Responsibilities

·       Support material information organization to effectively respond to material information requests throughout the organization

·       Provide guidance in product development and material selection to ensure device materials meet global material information criteria as well as design requirements

·       Support shared regulatory material information between Cook entities

·       Work with IT, Business Insights to build internal material information databases

·       Track material compliance requirements with appropriate medical device standards and regulations

·       Develop material information guidance documents to disperse across the organization

·       Support development of corporate level policies and procedures to standardize the approach to management of raw materials

·       Collaborate and take direction, as appropriate, from Biocompatibility Scientists, Regulatory Scientists, and Engineering personnel to ensure appropriate and timely execution of regulatory submission documents

·       Assist Biocompatibility Specialists, Toxicologists and Engineers in procuring adequate documentation that will facilitate development of safety/risk assessments

Qualifications

·       Bachelor''s degree in material science, chemistry, chemical engineering or a relevant life sciences degree; Master''s degree preferred

·       Minimum 3 years’ experience in the medical device and/or pharmaceutical industry with exposure to material regulations such as EU MDR, REACH, Prop 65, RoHS

·       In-depth understanding of ISO 10993 and chemical characterization

·       In-depth knowledge of common medical device materials (polymers) and additives

·       Experience with analytical material characterization (DSC, TGA, FTIR, MI, etc.)

·       Demonstrated ability to manage and execute multiple projects

·       Understanding of applicable guidelines and regulations

·       Works under general office environmental conditions with sitting for extended periods