Biocompatibility Engineer

1 week ago

San Clemente, California, United States Entegee Full time
About the Role

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

Key Responsibilities:

  • Conduct biocompatibility tests and analyze results to ensure compliance with regulatory standards
  • Collaborate with cross-functional teams to develop and implement biocompatibility strategies
  • Assist with regulatory submissions and address biological safety concerns in design reviews
  • Contribute to the development of biocompatibility-related documentation
  • Maintain effective communication with employees, customers, contractors, and vendors

Requirements:

  • BS degree in a relevant field (e.g., biomedical engineering, biology, chemistry)
  • Minimum 2 years of medical device industry experience
  • Understanding of ISO 10993 standards and biomaterials
  • Knowledge of toxicological risk assessment and extractable and leachable analysis
  • Familiarity with medical device manufacturing processes
  • Proficient in MS Office

Preferred Qualifications:

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

Salary Range: $40-$60 per hour

Benefits:

  • Medical, dental, and vision insurance
  • Term life insurance and short-term disability insurance
  • Additional voluntary benefits
  • Commuter benefits
  • 401K plan

Equal Opportunity Employer/Veterans/Disabled

We consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements.

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