Pay Rate: $93.98
2 Years+ Contract
We are seeking an experienced, Senior 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 Biocompatibility Group as part of R&D Science and Technology Group. This role will work closely with internal biocompatibility SME's and directly with program/project cross-functional teams to provide biocompatibility risk assessments, test 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).
Must have strong ability to interpret biocompatibility standards/guidance and apply regulatory requirements as appropriate to product development and change activities for assigned devices. Candidate must have strong ability to identify required inputs, critically review and evaluate scientific information, and assess the significance of any gaps identified.
? Develop biocompatibility risk assessments in consideration of prior and available materials, design and process information. Evaluate biological risk assessment in order to identify information gaps and discern which warrant additional testing and which do not.
? Propose potential testing strategies that satisfy timeline, cost, technical, and biological safety requirements. Critically review protocols, reports, toxicological risk assessments, and regulatory summaries in collaboration with cross-functional program teams, test
laboratories, and suppliers
? Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations
? Interface with key business partners as directed and represent biocompatibility team on project/program teams
? Provide leadership and technical guidance to scientist/Specialist I and II of the Biocompatibility team
Experiences, education, and knowledge requirements:
? BS in one or more of the following disciplines: Biomedical Engineering, Bioengineering,
Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Chemistry, Materials Science, or Toxicology. Extensive relevant job experience will be considered and can satisfy degree requirements.
? 4-6 years' industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, and/or special process
? Fundamental understanding or direct experience of the ISO 10993 standards, ISO 10993 biocompatibility materials and process risk assessment, biomaterials, toxicological
assessment, extractable and leachable analysis, and medical device manufacturing processes
? Demonstrated ability to draw risked based 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.