Biocompatibility Specialist

Biocompatibility Specialist

This position involves the review, planning, and execution of biocompatibility assessments to ensure that biosafety information is accurate and supports business objectives. The role requires a primary commitment to patient safety and product quality, with a specific focus on orthopedics. The specialist will contribute to testing strategies, author and approve biocompatibility reports, and support various new product development and lifecycle management projects.

• Review, plan, and perform biocompatibility assessments to ensure biosafety information is accurate and reliable.
• Provide input to testing strategies, write and approve biocompatibility assessments and reports, and assess test data.
• Strategize testing plans to meet project deliverables and schedules.
• Provide guidance on testing related to new investigational and strategic device development programs.
• Serve as a resource for biocompatibility evaluation for medical devices and materials, including issues related to additives, solvents, and metals.
• Offer consultation on biocompatibility and toxicological issues, supporting problem-solving.
• Communicate effectively across functions with departments such as Product Development, Regulatory, Manufacturing, and Quality.
• Support multiple projects simultaneously, including new product development and product lifecycle management.

• BS in Biology, Chemistry, Engineering, or a related science with 3-4 years of experience in the medical device industry.
• Knowledge of biocompatibility evaluations for medical devices (ISO 10993-1).
• Experience in reviewing and performing biocompatibility assessments for medical devices.
• Ability to write and approve biocompatibility assessments and reports.
• Applied knowledge of biocompatibility evaluation principles, regulatory standards, and best practices.
• Knowledge of design control and management processes as per ISO 13485.

• MS/PhD in Biology, Chemistry, Engineering, or a related science with 3-4 years of experience in medical devices.
• Experience with toxicological risk assessments of leachables and extractables of medical device materials.
• Applied knowledge of toxicology principles, regulatory standards, and best practices.

For this opportunity, you will also be eligible for benefits through Apex for the contract period, 401K, medical/health benefits options, a W2 hourly rate, weekly pay, and direct deposit!