Senior Scientist – Raw Material Analysis & Specification Development

Job Description: Senior Scientist – Raw Material Analysis & Specification Development

Job Summary

In this role, you will lead the technical evaluation, characterization, and qualification of raw materials used in medical devices, including polymers, elastomers, metals, coatings, and other functional materials. You will evaluate raw material testing specifications, review purchasing specifications, assess supplier documentation, and establish scientifically justified acceptance criteria to ensure materials meet product, quality, and regulatory requirements.

Working closely with R&D, analytical sciences, quality, procurement, supplier quality, and manufacturing teams, you will conduct material characterization, assess material variability, evaluate alternate materials and suppliers, and establish correlations between raw material properties and medical device performance. You will also support material qualification, change control, and investigations to ensure consistent material quality and reliable medical device manufacturing.

Essential Duties and 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 ensure alignment with product requirements, supplier specifications, and internal quality standards.
  
• Analyse supplier technical data sheets, Certificates of Analysis (CoAs), safety data sheets, and other relevant technical documentation to assess material compliance.
  
• Characterize raw materials using appropriate analytical techniques, such as FTIR, DSC, TGA, GPC/SEC, rheology, moisture analysis, chromatography, and mechanical testing, as applicable.
  
• 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.
  

Education

• 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. degree in a relevant discipline may also be considered with suitable industry experience.
  

Work Experience

• 5–8 years of relevant experience in raw material characterization, analytical testing, material qualification, or specification development, preferably in the medical device, pharmaceutical, healthcare, or regulated manufacturing industry.
  
• 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.
  

Preferred Knowledge, Skills, and Abilities

• 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.
  
• Familiarity with ISO 13485, ISO 14971, ISO 10993, and relevant ASTM, ISO, or USP standards, as applicable.
  
• 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.
  

Additional Requirements

• 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.