Materials Engineer

Materials Engineer - Toxicology Backgrounbd

Our client is seeking a Materials Engineer to join a multidisciplinary team supporting product development, material qualification, biocompatibility activities, and regulatory documentation for medical technologies used in highly regulated environments.

This role combines material science expertise with technical writing, risk assessment, and regulatory support. The successful candidate will work closely with engineering, quality, research and development, and regulatory teams to evaluate materials, support design changes, and ensure compliance with applicable regulatory and quality requirements.

Key Responsibilities

• Evaluate and qualify materials for use in regulated medical products.
• Assess material properties, compatibility, performance, and safety for intended applications.
• Support biological safety and biocompatibility evaluations.
• Develop technical reports, risk assessments, scientific justifications, and supporting documentation.
• Author and review material-related documentation for regulatory submissions and quality system requirements.
• Interpret laboratory testing results and material characterization data.
• Evaluate the impact of material, supplier, manufacturing, sterilization, packaging, and formulation changes.
• Collaborate with suppliers, laboratories, and internal stakeholders to support material investigations and product development initiatives.
• Support design control activities, verification testing, validation efforts, and change management processes.
• Assist with material-related technical questions from regulatory agencies, customers, and internal teams.

Qualifications

• Bachelor's degree in Materials Engineering, Polymer Science, Biomaterials, Chemistry, Chemical Engineering, or a related scientific discipline.
• 3+ years of experience in medical devices, life sciences, biotechnology, pharmaceuticals, or another regulated industry.
• Experience working with polymeric materials, biomaterials, or material characterization.
• Strong technical writing and documentation skills.
• Experience preparing scientific reports, risk assessments, or regulatory documentation.
• Familiarity with ISO 10993, ISO 14971, FDA, EU MDR, or comparable regulatory frameworks.
• Ability to analyze scientific data and draw evidence-based conclusions.

Preferred Experience

• Biocompatibility, biological evaluation, or material safety assessment experience.
• Chemical characterization, extractables, or analytical laboratory experience.
• Product development experience within a regulated environment.
• Experience supporting audits, regulatory submissions, or quality system documentation.
• Cross-functional collaboration with engineering, quality, and regulatory teams.

What We're Looking For

We're seeking a materials professional who enjoys the intersection of science, engineering, and regulatory compliance. The ideal candidate brings hands-on experience with polymers or biomaterials, strong analytical capabilities, and a demonstrated ability to develop clear, thorough technical documentation in support of regulated products.