This position will have the option to work a hybrid schedule, with two days from home after three months of employment, with the remainder working in our office out of Schaumburg, IL.
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 individual's 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 $105K commensurate with experience
Benefits: 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-oriented
RESPONSIBILITIES The job responsibilities of this position may include, but are not limited to:
- Write the Biocompatibility Evaluation Plan and Report for developing products
- Create product specific testing plans, including recommended biological testing per ISO 10993 and justifications
- Perform toxicological risk assessments per ISO 10993
- 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 products
QUALIFICATIONS Required - Master's 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 FDA's 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.
- Demonstrated independence.
- 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 company's success!
EOE
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