Biocompatibility Specialist

Key Responsibilities: 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.

Required Qualifications: 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.

Preferred Qualifications: 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!