Senior Biocompatibility Specialist

3 weeks ago


San Clemente, California, United States Entegee Full time
Job Overview

We are seeking a highly skilled Senior Biocompatibility Specialist to join our team at Entegee, a leading provider of custom automation solutions.

Estimated Salary: $48.00 per hour

Job Description

As a Senior Biocompatibility Specialist, you will be responsible for conducting biocompatibility assessments and evaluations in compliance with biological evaluation standards.

You will analyze biocompatibility test results, assist with regulatory submissions, and address biological safety concerns in design reviews.

Additionally, you will contribute to the development and implementation of biocompatibility strategies, conduct sample preparation feasibility testing, and write biological evaluation plans, reports, and other biocompatibility-related documentation.

Key Responsibilities:

  • Conduct biocompatibility assessments and evaluations in compliance with ISO 10993 standards
  • Analyze biocompatibility test results and provide recommendations for improvement
  • Assist with regulatory submissions and address biological safety concerns in design reviews
  • Develop and implement biocompatibility strategies to ensure compliance with industry regulations
  • Conduct sample preparation feasibility testing and develop protocols for biocompatibility testing
  • Write biological evaluation plans, reports, and other biocompatibility-related documentation
Requirements and Qualifications

To be successful in this role, you must have a BS degree in a relevant field and a minimum of 2 years of medical device industry experience.

You should have a strong understanding of ISO 10993 standards and knowledge of biomaterials, toxicological risk assessment, and extractable and leachable analysis.

Familiarity with medical device manufacturing processes and proficiency in MS Office are also required.

Preferred Skills:

  • Experience with regulatory submissions and familiarity with medical device manufacturing processes
  • Knowledge of biological safety in design processes and ability to communicate effectively with cross-functional teams
Benefits

We offer a competitive salary range of $40.00 to $60.00 per hour and a comprehensive benefits package that includes medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan.

Benefit Highlights:

  • Medical, dental, and vision coverage for employees and their families
  • Life insurance and short-term disability coverage
  • Additional voluntary benefits, including accident, critical illness, and hospital indemnity insurance
  • EAP program providing confidential counseling services
  • Commuter benefits, including public transportation reimbursement
  • 401K plan with company match
Company Description

Entegee is a global leader in custom automation solutions, specializing in controls and robotic solutions.

We pride ourselves on delivering high-quality solutions that meet the unique needs of our clients.

About Us:

  • Global leader in custom automation solutions
  • Specializing in controls and robotic solutions
  • Delivering high-quality solutions that meet client needs


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