Biomaterials & Regulatory Materials Engineer

BioTalent; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Job summary

BioTalent is seeking a Materials Engineer to join a multidisciplinary team supporting product development, material qualification, biocompatibility activities, and regulatory documentation for medical technologies in regulated environments. The role combines material science with technical writing, risk assessment, and regulatory support.

You will work with engineering, quality, R&D, and regulatory teams to evaluate materials, support design changes, and ensure compliance with ISO 10993, ISO

Qualifications

• Bachelor’s degree in a materials or related scientific discipline.
• 3+ years in medical devices or regulated industry.
• Experience with polymeric/biomaterials or material characterization.
• Strong technical writing and documentation skills.

Responsibilities

• Evaluate and qualify materials for regulated medical products.
• Assess material properties, compatibility, performance and safety.
• Support biocompatibility evaluations and regulatory documentation.
• Develop technical reports, risk assessments, and scientific justifications.
• Author/review material documentation for regulatory submissions and QMS.
• Interpret lab testing and material characterization data.
• Collaborate with suppliers and internal teams on material investigations.
• Support design control, verification, validation, and change management.

Skills

Material science

Regulatory writing

Risk assessment

Data analysis

Technical writing

Education

Bachelor's degree in Materials Eng./Polymer Science/Biomaterials/Chemical Eng.

Job description

BioTalent is seeking a Materials Engineer to join a multidisciplinary team supporting product development, material qualification, biocompatibility activities, and regulatory documentation for medical technologies in regulated environments. The role combines material science with technical writing, risk assessment, and regulatory support.

You will work with engineering, quality, R&D, and regulatory teams to evaluate materials, support design changes, and ensure compliance with ISO 10993, ISO