USA Senior Scientist – Raw Material Analysis & Specification Development

HealthMinds Consulting Pvt. Ltd; Arizona; On-site; USD 120,000 - 180,000; Full time

Job summary

HealthMinds Consulting Pvt. Ltd. seeks a USA Senior Scientist to lead evaluation, characterization, and qualification of raw materials for medical devices, including polymers, elastomers, metals, coatings, and other functional materials.

You will review testing specs, supplier documentation, and establish acceptance criteria to ensure material quality, regulatory compliance, and product reliability across R&D, QA, procurement, and manufacturing teams.

Qualifications

• MS/M.Tech in Materials Science, Polymer Science, Chemistry, Analytical Chemistry, or related field.
• 5–8 years in raw material characterization, analytical testing, or specification development.
• Experience reviewing CoAs, SDS, and material compliance documentation.
• Familiarity with analytical techniques for polymers, elastomers, metals, coatings, or functional materials.
• Knowledge of quality systems, change control, risk assessment, and technical documentation.

Responsibilities

• Evaluate and develop raw material testing specifications, including test parameters and acceptance criteria.
• Review and optimize raw material purchasing specifications for product alignment.
• Analyse supplier CoAs, CoAs, safety data sheets, and other docs for compliance.
• Characterize raw materials using FTIR, DSC, TGA, GPC/SEC, rheology and mechanical testing.
• Establish scientifically justified acceptance limits based on data and risk.
• Evaluate new materials, alternate grades, and supplier changes via comparative analyses.
• Investigate material variability and out-of-spec issues.
• Support qualification, supplier approval, and change control processes.
• Assess impact of material properties on biocompatibility and sterilization compatibility.
• Collaborate with R&D, analytical, quality, procurement, and manufacturing teams.
• Prepare evaluation reports and technical documentation per quality-system requirements.
• Identify opportunities to improve raw material quality and supplier controls.

Skills

FTIR

DSC

TGA

GPC/SEC

Rheology

Moisture analysis

Chromatography

Mechanical testing

Analytical thinking

Cross-functional collaboration

Education

M.S./M.Tech in Materials Science and Engineering

B.E./B.Tech in a relevant discipline with experience

Tools

CoAs review process

Technical documentation tools

Job description

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

Location: Scottsdale, USA

Type: On-site

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.