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.
Our Neuromodulation business is an area of expertise for Abbott. This business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. Our Solutions include Proclaim (TM) XR SCS System, the #1 Spinal cord stimulator on the market, Proclaim (TM) DRG Neurostimulator, the only FDA approved DRG therapy and a market leader in radiofrequency ablation therapy, Abbott RFA. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Our deep brain stimulation technology for progressive diseases help people manage their Parkinson's disease and essential tremor symptoms, steering away from side effects.
Our location in Plano, TX
has an opportunity for a Staff Biocompatibility Scientist
We are seeking an experienced, high caliber Staff Biocompatibility Scientist 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 Neuromodulation R&D Group as a Subject Matter Expert (SME) in biocompatibility.. This role will work closely with program/project cross-functional teams to provide biocompatibility strategy and 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 strong ability to interpret biocompatibility regulatory requirements and guidance and apply regulatory requirements as appropriate to product development and change activities for assigned devices. Candidate must have strong ability to critically review detailed scientific information and assess any gaps based on adequately supported data. Candidate must be able to identify and assess business/technical project risks and recommend/influence contingency plans for risk mitigation.WHAT YOU'LL DO
EDUCATION AND EXPERIENCE YOU'LL BRING: Required
- Develop biocompatibility strategies in consideration of gaps in materials, design and process to achieve optimal solutions that satisfy timeline, cost and technical requirements as they relate to biological safety
- Critically review protocols, reports, toxicological risk assessments, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers
- Evaluate and execute 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
- Develop and deliver regulatory submission responses to biocompatibility related questions
- Identify and interface with key business partners and represent biocompatibility team on project/program teams
- Influence organization excellence by recommending approaches, procedures, and work aids as they relate to biocompatibility, in compliance with applicable global regulatory requirements (e.g. FDA, ISO, MHLW, and CFDA)
- Provide leadership and technical guidance to Scientist/Specialist I and II of the Biocompatibility team
WHAT WE OFFER
- BS in one or more of the following disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; advanced degree (MS or PhD) preferred although comparable areas of study and industry experience is considered for the position
- 7+ years' industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, and/or special process validation
- 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.
At Abbott, you can have a good job that can grow into a great career. We offer:
Learn more about our benefits that add real value to your life to help you live fully:?
- 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
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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