Biocompatibility Specialist

We are seeking a highly skilled Biocompatibility Engineer to join our team at Entegee. As a Biocompatibility Engineer, you will be responsible for conducting biocompatibility assessments and evaluations in compliance with biological evaluation standards.

Key Responsibilities:

• Conduct biocompatibility assessments and evaluations in compliance with biological evaluation standards
• Analyze biocompatibility test results
• Assist with regulatory submissions and address biological safety concerns in design reviews
• Contribute to the development and implementation of biocompatibility strategies
• Conduct sample preparation feasibility testing
• Write biological evaluation plans, reports, and other biocompatibility-related documentation
• Maintain communication with employees, customers, contractors, and vendors

Requirements:

• BS degree in a relevant field
• 2+ years of medical device industry experience
• Understanding of ISO 10993 standards
• Knowledge of biomaterials, toxicological risk assessment, and extractable and leachable analysis
• Familiarity with medical device manufacturing processes
• Proficient in MS Office

Preferred Skills:

• Experience with regulatory submissions
• Knowledge of biological safety in design processes

Pay: $40.00 to $60.00 per hour

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 401K plan.

Equal Opportunity Employer/Veterans/Disabled

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