Biocompatibility Specialist II

Job Description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Leading an active lifestyle is important to the many people we serve. In Abbott’s ELECTROPHYSIOLOGY & HEART FAILURE division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in EP/HF, allowing people to restore their health and get on with their lives.

WHAT YOU'LL DO:

We are seeking an experienced Biocompatibility Specialist who will make an important contribution to patient safety by supporting projects/programs in terms of biocompatibility of medical devices, materials, and processes. The person will represent the Biocompatibility Group as part of R&D Science and Technology Group as a Subject Matter Expert (SME) in biocompatibility. This role will work closely with Senior Biocompatibility Specialists and program/project cross-functional teams to provide biocompatibility protocols and reports. The role requires ability to critically review test lab reports and other deliverables in compliance with global regulatory requirements such as ISO 10993. The role requires knowledge of the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations and guidance that affect assigned devices (Class I to Class III). Candidate must have working knowledge and ability to interpret biocompatibility regulatory requirements and guidance in order to support product development and change activities for assigned devices. Candidate must have the ability to critically review detailed scientific information and assess any gaps.

Job Description:

Essential Responsibilities:

• Gather necessary data sets, and draft biocompatibility assessments, protocols and reports necessary for establishing biological safety evaluations
• Critically review protocols, reports, toxicological risk assessments, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers
• Evaluate and plan biocompatibility studies in support of programs dealing with Class I to Class III medical devices
• Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations
• Identify and interface with key business partners and represent biocompatibility team on project/program teams

EDUCATION & EXPERIENCE YOU'LL BRING:

Experiences, education, and knowledge requirements:

• BS in one or more of the following disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; although comparable areas of study and industry experience is considered for the position. Extensive relevant job experience will be considered and can satisfy degree requirements.
• 3-5 years’ industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, and/or special process validation
• Must have fundamental understanding or direct experience of the ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology
• Demonstrated ability to draw conclusions, present and make recommendations based on technical inputs from multiple and varied functions
• Must be team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with all organizational levels
• Excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site and multi-business unit
• Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables
• Must possess strong analytical and process skills, and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc.

WHAT WE OFFER:

At Abbott, you can have a good job that can grow into a great career. We offer:

· Training and career development, with onboarding programs for new employees and tuition assistance

· Financial security through competitive compensation, incentives and retirement plans

· Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

· Paid time off

· 401(k) retirement savings with a generous company match

· The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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