Materials Scientist

Overview

The Materials Scientist at Cook Polymer Technology is responsible for working collaboratively with biocompatibility specialists, regulatory scientists, toxicologists, engineers, project management, and internal and external stakeholders to develop regulatory submission documents that contain proper material information. The Materials Scientist is responsible for providing materials and processing support to production. The Scientist is also responsible for working to develop material related synergies between production departments, and supporting related continuous improvement work. The Materials Scientist leads the Material Review Board, and coordinates and dispositions all Material Non- Conformances. Works with regulatory, R&D, and customers on supplier initiated material changes. Assists product development with material selection guidance and design for manufacturability requirements on new products, and supports new capital equipment and tooling purchases.

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 regulation criteria as well as design requirements• Assist in device design change evaluation related to supplier-initiated and Cook-initiated changes• Assist in responding to deficiency responses from regulatory agencies related to material information• Track material compliance requirements with appropriate medical device standards and regulations• Serve as a technical lead on materials-related projects• Research and develop technical white papers to disperse material knowledge 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 Specialists, 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• 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• Ability to read, write, and compile technical documents• Ability to work collaboratively with team members in a local and global environment• Excellent analytical and problem-solving skills• Effective oral, written and presentation communication skills• Enthusiastic to be mentored/developed by experienced individuals in the biocompatibility & toxicology team

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

Physical Requirements:

• Works under general office environmental conditions• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.• Frequently required to sit, stand, walk, and communicate• Must be able to perform the essential functions of the job, with or without reasonable accommodations• Ability to travel over-night up to 10% of time, if needed