Job Title - Biocompatibility Specialist/ Medical device/SME
Job Location - Saint Paul MN
Contract - 24+ months (possible extension).
Job Description Summary:
- seeking an experienced 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 assessments, 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 working knowledge and ability to interpret biocompatibility regulatory requirements and guidance in order to support product development and change activities for assigned devices. Candidate must have the ability to critically review detailed scientific information and assess any gaps.
- Candidate must be able to identify and assess business/technical project risks and recommend/influence contingency plans for risk mitigation.
- Conduct biocompatibility assessments and identify any gaps in device, materials, design and process necessary to meet 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
- Identify and interface with key business partners and represent biocompatibility team on project/program teams
Additional job description:
- Experiences, education, and knowledge requirements:
- 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) beneficial although comparable areas of study and industry experience is considered for the position
- 3-7 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, 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.
Experis is an Equal Opportunity Employer (EOE/AA)