Biocompatibility Specialist
Company: BISCO
Location: Hanover Park
Posted on: May 28, 2023
Job Description:
We are seeking a Biocompatibility Specialist that is ready to
leverage their technical writing, project management, and medical
device industry experience in a dynamic and collaborative workplace
environment.The Biocompatibility Specialist represents the
biocompatibility domain as part of the Research and Development
Department by acting as a Subject Matter Expert (SME). The
individuals strong knowledge of ISO 10993 enables them to identify
biocompatibility requirements, planning, execution, and approval of
biocompatibility activities to support regulatory submissions and
requirements. The individual also reviews and maintains
biocompatibility evaluations for existing products. The individual
works closely with product development and regulatory teams to
provide strategy and deliverables that are compliant with
biocompatibility requirements. The ideal individual has proven
experience and success in working with external testing labs,
determining relevant biocompatibility testing, and writing of ISO
10993 compliant reports. The role may also require developing and
executing experimental studies to support the biological safety of
medical devices as part of the product development and early
research.Salary range: $90K to $106K commensurate with
experienceBenefits: Medical, dental, and vision insurance, HRA and
FSA, short and long-term disability, life insurance, PTO, 401(k)
profit-sharing with match, potential year-end bonuses.This person
is ideally:
- Respectful, positive, and a team player
- Adaptable, approachable, and always smiling
- Willing to learn and a quick learner
- Goal-driven, organized and detail-orientedThis position will be
required to work out of the Schaumburg, IL office, aside from the
option to work-from-home once per week after three months of
employment.RESPONSIBILITIESThe job responsibilities of this
position may include, but are not limited to:
- Write the Biocompatibility Plan and Report for developing
products
- Create product specific testing plans, including recommended
biological testing per ISO 10993 and justifications
- Review and maintain existing Biocompatibility Evaluations for
current products
- Ensure compliance of Biocompatibility Evaluations with global
regulatory requirements; stay current with biocompatibility
compliance and requirements
- Analyze and interpret biological test results
- Act as biocompatibility SME during product development and
audits
- Act as the main contact between external testing labs and
BISCO
- Negotiate and manager projects with external labs
- Coordinate test sample preparation between labs and BISCO
- Source external testing or research labs and other vendors
- Develop and execute experimental testing protocols to support
biocompatibility characterization of materials and
productsQUALIFICATIONSRequired
- Masters or PhD degree in life sciences or physical sciences.
Degree in biology, biochemistry, toxicology, or similar discipline
preferred.
- 1 to 3+ years work experience (dependent on education).
Experience with biocompatibility requirements and testing for
medical devices highly preferred.
- General computer skills and proficiency in MS Office
applications.
- Strong knowledge of ISO10993 and FDAs Biological Evaluation
Guidance and expectations; working knowledge of ISO 14971 and
GMP/GLP.
- Knowledge of biocompatibility test methods.
- Scientific analytical and writing skills.
- Solid multi-tasking and time management skills.
- Negotiation skills.
- Legally authorized to work in the U.S. and do not now, and will
not in the future, require sponsorship for employment visa status
to work for our company.WHY BISCO, INC.?Bisco, Inc. stands out
because of our culture and core values:
-
- Respectful Professional. Humble. Considerate.
- Positive Friendly. Inclusive. Curious.
- Team Player Helpful. Cooperative. Flexible.
- Agility of a small company but the stability of a big
company
- Industry-leading dental restorative products
- Broad exposure to activities across the company
- Family-oriented environment with positive team players
- Approachable, respectful, and down-to-earth people
- Long-tenured employees to whom the leadership is committed
- Employees feel valued and are proud to be a part of the
company
- Monthly whole-company fun events!Since 1981, BISCO has provided
innovative dental restorative products to dental customers around
the world. Our primary focus is adhesive and composite technology.
Located northwest of Chicago in Schaumburg, our ISO 13485 certified
facility includes on-site manufacturing and research. Our
privately-owned organization provides the opportunity for a
close-knit environment that encourages inter-departmental
collaboration. For more about us, please visit our website at .This
is an excellent opportunity to make an impact and to grow
professionally, while contributing to the companys success!EOENo
agencies pleasePI216485571
Keywords: BISCO, Chicago , Biocompatibility Specialist, Other , Hanover Park, Illinois
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