USA Senior Scientist – Raw Material Analysis & Specification Development
About The Position
The Senior Scientist leads the technical evaluation, characterization, and qualification of raw materials used in medical devices, including polymers, elastomers, metals, coatings, and other functional materials. The role evaluates raw material testing and purchasing specifications, supplier documentation, and scientifically justified acceptance criteria to ensure materials meet product, quality, and regulatory requirements. Working with R&D, analytical sciences, quality, procurement, supplier quality, and manufacturing teams, the Senior Scientist characterizes materials, assesses variability, evaluates alternate materials and suppliers, and establishes correlations between raw material properties and medical device performance. The role also supports material qualification, change control, and investigations to promote consistent material quality and reliable medical device manufacturing. Laboratory R&D activities and applicable laboratory safety procedures are part of the work.
Requirements
- M.S. or M.Tech. in Materials Science and Engineering, Polymer Science, Chemistry, Analytical Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline; a B.E./B.Tech. in a relevant discipline may also be considered with suitable industry experience.
- 5–8 years of relevant experience in raw material characterization, analytical testing, material qualification, or specification development; medical device, pharmaceutical, healthcare, or regulated manufacturing experience is preferred.
- Hands-on experience evaluating raw material testing specifications, acceptance criteria, and purchasing specifications.
- Experience reviewing supplier CoAs, technical data sheets, and material compliance documentation.
- Practical knowledge of analytical techniques for polymer, elastomer, metal, coating, or other functional material characterization.
- Experience with material equivalence assessments, supplier changes, root-cause investigations, and material-related quality issues.
- Familiarity with quality systems, change control, risk assessment, and technical documentation.
- Ability to perform laboratory R&D activities and follow applicable laboratory safety procedures.
- Strong attention to detail, documentation practices, and data integrity.
- Ability to manage multiple tasks, interpret technical information, and make sound technical recommendations.
- Effective written and verbal communication skills.
Nice To Haves
- Familiarity with ISO 13485, ISO 14971, ISO 10993, and relevant ASTM, ISO, or USP standards, as applicable.
- Strong understanding of raw material properties, testing methodologies, specification limits, and supplier qualification requirements.
- Working knowledge of analytical techniques such as FTIR, DSC, TGA, GPC/SEC, chromatography, rheology, and mechanical testing.
- Ability to interpret analytical data, identify specification gaps, and recommend technically justified acceptance criteria.
- Understanding of medical device material compatibility, biocompatibility, sterilization, and chemical characterization requirements.
- Strong analytical thinking, problem-solving, technical writing, and cross-functional collaboration skills.
Responsibilities
- Evaluate and develop raw material testing specifications, including test parameters, analytical methods, sampling requirements, and acceptance criteria.
- Review and optimize raw material purchasing specifications to align with product requirements, supplier specifications, and internal quality standards.
- Analyze supplier technical data sheets, Certificates of Analysis (CoAs), safety data sheets, and other technical documentation to assess material compliance.
- Characterize raw materials using applicable analytical techniques, including FTIR, DSC, TGA, GPC/SEC, rheology, moisture analysis, chromatography, and mechanical testing.
- Establish scientifically justified acceptance limits based on material properties, historical data, supplier capabilities, product requirements, and risk assessments.
- Evaluate new materials, alternate grades, and supplier changes through comparative analysis and material equivalence assessments.
- Investigate material variability, out-of-specification results, contamination, and material-related manufacturing or product performance issues.
- Support raw material qualification, supplier approval, incoming inspection optimization, change control, and nonconformance investigations.
- Assess the impact of raw material properties on medical device functionality, processability, biocompatibility, sterilization compatibility, and product reliability, as applicable.
- Collaborate with R&D, analytical, quality, procurement, and manufacturing teams to resolve material-related technical challenges.
- Prepare material evaluation reports, specification justifications, qualification protocols, and technical documentation in accordance with applicable quality-system requirements.
- Identify opportunities to improve raw material quality, strengthen supplier controls, and optimize material testing requirements.
- Perform laboratory R&D activities and follow applicable laboratory safety procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
