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Staff Biocompatability Specialist

In Minnesota / United States

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Staff Biocompatability Specialist   

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JOB TITLE:

Staff Biocompatability Specialist

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

St. Paul Minnesota / United States

JOB DESCRIPTION:

"Exempt/Non Exempt: Non Exempt
Years Experience: 5-7 years’ industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, and/or special process validation Skills:
Skills: 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.
Education: 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) preferred although comparable areas of study and industry experience is considered for the position

Duties: 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 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 critically review detailed scientific information and assess any gaps based on adequately supported data. Candidate must be able to identify and assess business/technical project risks, and recommend/influence contingency plans for risk mitigation.

Essential Responsibilities:
Develop biocompatibility strategies in consideration of gaps in materials, design and process to achieve optimal solutions that satisfy timeline, cost and 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 , 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
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"

Position Details

POSTED:

Apr 17, 2022

EMPLOYMENT:

INDUSTRY:

Health Care

SNAPRECRUIT ID:

S1643918409219696

LOCATION:

Minnesota / United States

CITY:

St. Paul

Job Origin:

Jobsrus_organic_feed

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In Dallas Fort Worth
Aug 19, 2017 9am-6pm
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Staff Biocompatability Specialist    Apply

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"Exempt/Non Exempt: Non Exempt
Years Experience: 5-7 years’ industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, and/or special process validation Skills:
Skills: 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.
Education: 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) preferred although comparable areas of study and industry experience is considered for the position

Duties: 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 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 critically review detailed scientific information and assess any gaps based on adequately supported data. Candidate must be able to identify and assess business/technical project risks, and recommend/influence contingency plans for risk mitigation.

Essential Responsibilities:
Develop biocompatibility strategies in consideration of gaps in materials, design and process to achieve optimal solutions that satisfy timeline, cost and 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 , 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
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"


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