Support functions across the organization by solving material problems to develop and improve medical devices and manufacturing processes while advancing the strategic goals of the company. Contribute technical/scientific expertise in the areas of material design, material change, failure mode analysis and root cause analysis, and help solve department, system-level material problems/issues. Overseeing a team while also executing and analyzing material characterization studies (DSC, TGA, FTIR, MI) to define expected performance margin relative to design targets. Develop material-based process and procedure, including material degradation studies (UV, VHP, environmental). Assist or provide guidance to various departments on multiple large scale technical projects. Respond to regulatory material questions and adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
1. Master of Science degree in Materials Science or Polymer Science.
2. Five (5) years of experience in the Medical Device Industry.
3. One (1) year of experience in a chemical industry with hands-on experience in a polymer chemistry laboratory setting. This experience may have been gained as part of or in addition to the Medical Device Industry experience.
4. Additional experience must include:
• Serving as a technical lead, managing multiple independent projects and tasks from product inception through launch and maintenance.
• Ensuring products met quality standards and complied with all design control and regulatory requirements.
• Supporting Supplier Change Projects, Design Changes, Complaint Investigations and New Product Development.
• Serving as a subject matter expert (SME) on EU MDR restricted substances (CMRs and EDs).
• Collaborating with New Product Development, Sustaining Engineering, and suppliers to identify and develop cost-effective alternatives for materials of concern.
• Use of third-party systems to interact with suppliers in gathering material information for use for regulatory compliance.
• Providing technical expertise to support Biocompatibility Assessments and serving as a liaison between engineering and biocompatibility teams to ensure alignment and compliance.
• Technical writing, including conducting and summarizing literature studies to support regulatory justifications (e.g., authoring industrial white papers, deficiency responses, and technical analyses).
• Developing processes (i.e. job aids) for general users to more effectively understand/interact with material team members (material collection, material database, contractor processes, etc.)
• Communicating technical information and concepts to diverse audiences, including technical teams, laypersons, and regulatory authorities.
• Mentoring and overseeing a team of material scientists and engineers.
• Hands-on experience with synthesis of polymers and chemical formulation.
• Polymer analysis and characterization using DSC, FTIR, TGA.
• Polymer adhesives and coatings, including the design and development of an adhesive or coating system.
• Polymer processing (i.e., compounding, extrusion, bonding, coating) and mechanical/physical testing (i.e., tensile, elongation).
• Chemistry of polyolefins, polyimides, polysiloxanes, polyamides, fluoropolymers, polyvinylchloride, thermoplastic elastomers (urethane and nylon-based) and molding polymers such as polyacetals and polycarbonates.
• Real time aging and theory for accelerated aging of polymers.
• Application of ASTM standards to material studies (i.e., degradation, aging, nanomaterials).
5. This role is a hybrid position. Must reside within two (2) hours via car of employer’s location, as required to work onsite 1-3 times per week.
6. Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
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