| Specialist/Subject Matter Expert - Polymer/Material/Analytical Chemistry || Mount View Ave, Minneapolis, MN 2. Santa Rosa, SFO, USA at Minneapolis, Minnesota, USA |
| Email: [email protected] |
| Hi Employer, Job Title Specialist/Subject Matter Expert - Polymer/Material/Analytical Chemistry - Urgent Mount View Ave, Minneapolis, MN 2. Santa Rosa, SFO, USA Note : Candidate experience shouldnt be more than 15 years. Job Responsibilities: Technical leadership for analytical and chemical characterization of polymer materials for medical devices. Evaluation of polymers/composites, additives, residues, etc., and identify gaps. Perform Chemical Composition Analysis to determine the presence of harmful substances like PFAS. Perform Alternate Material/Component and design Impact Analysis. Working experience in spectroscopy, thermal analysis, rheology, and mechanical property testing techniques. Data analysis, make data-driven recommendations, and present results to technical and non-technical stakeholders. In-depth knowledge of polymer materials with an ability to perform chemical analysis such as HPLC, GC-MS, FTIR, NMR, ICP-OES/MS etc, for establishing Extractables and leachables and biocompatibility of medical devices along with an understanding of Basic Toxicological Principles for Risk Assessment. Working experience with regulations and standards like EU MDR, FDA, ISO 10993-1, ISO 10993-12, ISO 10993-17, and ISO 10993-18 for medical devices is preferred. Screening and identifying CMRs / EDs, quantifying as per Medical Device Directives, and knowledge of REACH, RoHs, SVHCs, TSCA, Prop65, etc., is an added advantage. Support alternate material assessment, ensuring Certificates of Compliance (COC) and DMF-approved environmentally friendly materials. Sound knowledge of sterilization requirements for medical device components and equipment. Stay current with industry trends, regulations, and emerging technologies in polymer science. Responsible for project planning, scoping, and delivering test protocols, test cases, and test reports. Collaborate with external testing labs, external suppliers, and internal stakeholders. Support identified alternate material implementation at sites across the globe. Qualifications Masters / Bachelor of Science or Technology or Engineering in Polymer, Chemistry, Material Science, Chemical Engineering or Polymer Science / Engineering 10+ years of hands-on experience in Polymer Science, including R&D, manufacturing, and testing etc. Good stakeholder management (local and global). Proven ability to create results within budget, timeline, and product/project deliverables. Skills Excellent English verbal and written communication skills. Excellent data analysis, problem-solving, and critical thinking skills. Aware of regulatory requirements for polymer materials required for medical devices. Aware of polymer processing techniques and their applications. Proficient with materials testing methodologies, such as FTIR, GC-MS, HPLC, DSC, and chemical and function testing. Self-directed, resourceful, and able to work on multiple projects and priorities. Mohd Faisal -- Keywords: rlang information technology green card microsoft Minnesota |
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| Fri Dec 01 00:37:00 UTC 2023 |