Materials Scientist

Position Summary

This role will be responsible for technical leadership on regulatory compliance of materials supporting all business units and manufacturing sites globally. Will support cross-functional groups as the subject matter expert on material compliance and work alongside shared services partners on a global scale on informed material selection. Will also be hands-on in researching, analyzing, and databasing materials currently in production to allow optimization of materials across the entire Teleflex catalog globally. It is anticipated that this role will spend a portion of their time utilizing analytical chemistry techniques towards filling knowledge gaps in material formulations. Responsible for ensuring all products are compliant with industrial regulations for materials used in Teleflex devices.

Principal Responsibilities

•    Ensuring compliance with US, EU regulations and global regulatory requirements relating to the development, manufacture, and supply of medical devices and their materials of construction (e.g., REACH, Prop 65, RoHS).
•    Develop and manage library of restricted substances and materials regarding material compliance.
•    Complete gap assessments, identify products requiring material changes to ensure regulatory compliance or allow business continuity and initiate such projects with applicable business units.
•    Build and maintain a global database for historical data on materials across all business units in the Teleflex portfolio.
•    Designing experiments to evaluate material properties, including physical and chemical characterization of materials and biocompatibility.
•    Performing extractions of medical devices and medical device raw materials for analysis.  
•    Performing analysis of medical device extracts by chromatography methods per ISO 10993-18.
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures, and housekeeping standards.

Education / Experience Requirements

•    B.S. degree in Materials Science, Chemistry, Chemical Engineering, or related field AND 3+ years’ experience with medical device materials.
•    M.S. or PhD degree in Materials Science, Chemistry, Chemical Engineering, or related field AND 1+ years’ experience with medical device materials.
•    Confident in running targeted and/or non-targeted chromatography methods (HPLC, GC/MS) and interpreting results to make compound identifications. 
•    A good understanding of chemical legislation, REACH, CLP, RoHS, California Prop 65, and other general industrial regulations.
•    Working knowledge of material testing methodologies and general manufacturing/processing understanding. 
•    Experience in medical device regulations including biocompatibility and regulated material with a focus on biocompatible materials.
•    Experience with materials characterization techniques such as FTIR, SEM, EDS, GC-MS, LC-MS. 

Specialized Skills / Other Requirements

•    Project management skills
•    Experience effectively communicating complex technical concepts to both technical and non-technical audiences. 
•    Computer skills and software development, (i.e., data-base development, LIMS, statistical software and analysis, word processing for report generation, etc.)
•    Negotiation and problem-solving skills
•    Ability to operate and communicate effectively with multiple teams
•    Knowledge and experience in chemical evaluations focused on demonstrating safety
•    Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts 

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Working Conditions / Physical Demands

TRAVEL REQUIRED: Up to 10%

WORKING ENVIRONMENT:
☒ Office/Professional        ☐ Plant/Manufacturing    ☐ Remote/Field     ☒ Laboratory