Job Details

  • Title: Biocompatibility Scientist
  • Code: RCI-12597
  • Location: Saint Paul Minnesota (MN) 55117
  • Posted Date: 04/01/2021
  • Duration: 6 Months

  Job Description

Remote role but would prefer someone onsite

Top Skills

  • Biocompatibility exp is a must have
  • ISO 10993 (manager will ask a lot of questions about 10993 standards)
  • Local candidates preferred but willing to consider remote for right fit
Description
  • Primarily reviewing older data and putting it together and then writing reports
  • Can work 40-45 hours per week depending on work load
  • Interview: phone and then video
  • Education: 4 yr degree plus 2 plus yrs. experience
  • Current biocompatibility experience is a plus
  • Self-motivated
  • Present all finds to strategy team
  • Lot of reviewing older data
  • Find people that have MDR submission experience
  • Current experience is a huge advantage
  • Document control system (windchill) experience is a plus
  • Organized and self-driven
  • Request information
  • Client can provide training material but candidate should be self-motivated
  • Associates degree will work with 5 yrs. of experience
  • There is an opportunity for contract to hire
  • Not looking for a toxicologist
  • Risk assessment experience needed
Qualifications
  • 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 validation
  • 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