Offers “Abbott”

Expires soon Abbott

Staff Scientist - Biocompatibility

  • Santa Clara, Cuba
  • Chemistry / Biology / Agronomy

Job description

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

JOB DESCRIPTION:

Job Description

Provide and/or support biocompatibility evaluation and execute testing for Abbott Vascular products to ensure product compliance to ISO 10993 and other international standards.

Responsibilities:

  • Provide input to the biocompatibility risk assessment in product development, formulate testing strategy, and execute biocompatibility testing to ensure compliance to ISO 10993 and international regulatory standards for Abbott Vascular products under development.
  • Evaluate and provide biocompatibility impact assessment of any material and process related changes for existing products.
  • Liaison with external contract laboratories for conducting biocompatibility tests which include but are not limited to planning, scheduling, test method verification, protocols/reports generation and completions.
  • Serve as biocompatibility subject matter expert during product filing for regulatory approval process.
  • Provide biocompatibility expertise during internal and external suppliers' audits.
  • Ensure biocompatibility documentations are well organized and updated with most current regulations, standards, and industry practices.
  • May provide support in preclinical research projects.

Requirements:

  • Master or Ph.D. degree in biology and/or bioengineering, chemistry, chemical engineering with minimally 3 years industry experience (medical device industry preferred).
  • Experience in product development and familiar with ISO 10993, 21-CFR part 58 GLP regulations.
  • Hands on experience with Biocompatibility AND ISO 10993 is considered favorable for this position.
  • Demonstrated ability in writing protocol/report and perform statistical data analysis.
  • Proven experimental laboratory skills
  • Excellent communication skills
  • Excellent computer skills
  • Excellent digital file organization skills

OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL.

NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.

JOB FAMILY:

Research and Discovery

DIVISION:

AVD Vascular

LOCATION:

United States > Santa Clara : Building B - SC Floor-2

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

Yes

SIGNIFICANT WORK ACTIVITIES:

Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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