Sr. Scientist in Maplewood, MN at Volt

Date Posted: 5/14/2020

Job Snapshot

Job Description

Biocompatibility Specialist (6-month contract) **can work remote**

Volt is seeking a 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 material and process risk assessments, and test protocols/reports 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. Candidate must have ability to work cross functionally to obtain and review device design, history, materials and processing in compliance to ISO 10993-1 and generate reports and test protocols as necessary.

Responsibilities:

  • Develop biocompatibility material and process risk assessments in consideration of prior and available materials, design and process information.
  • Develop biocompatibility reports and test protocols as necessary.
  • Review protocols, reports, toxicological risk assessments, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers
  • Review, interpret, and draw conclusions with senior biocompatibility specialists from biocompatibility testing, including, extractable and leachable chemical characterization and biological evaluations
  • Identify and interface with key business partners and represent biocompatibility team on project/program teams

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.
  • 1-4 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, materials and process biological risk assessment, biomaterials, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology  
  • 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
  • Must possess strong analytical and process skills, and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc.

Volt is an Equal Opportunity Employer