Sr. Scientist in Maplewood, MN at Volt

Date Posted: 5/14/2020

Job Snapshot

Job Description

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

Volt is 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 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 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). 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 identify required inputs, critically review and evaluate scientific information, and assess the significance of any gaps identified. Candidate must be able to identify and assess business/technical project risks, and recommend/influence contingency plans for risk mitigation.

Responsibilities:

  • 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.
  • Develop optimal 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
  • 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

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; advanced degree (MS or PhD) preferred 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.
  • 5-7 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, 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.

Volt is an Equal Opportunity Employer