Biocompatibility Specialist

Company Overview

Argon Medical is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS!!

Position Overview

The role is responsible for overseeing the design and implementation of test systems and procedures for biocompatibility testing, performing scientific risk assessments to support design control activities, and evaluating new research and technology initiatives. The Toxicologist will apply subject matter expertise to solve complex biocompatibility problems, utilizing technical acumen, business experience and independent judgment.

What You Will Do

• Develop biological evaluation plans in accordance with company policies and procedures, support material/chemical characterization studies per ISO 10993-17 and ISO 10993-18 calculating NOAEL, TOEFL, and AET levels.
• Oversee a portfolio of related product development, product life cycle projects and must efficiently execute risk assessments, evaluations, support testing, and reporting, including biocompatibility and product chemical characterization.
• Work closely with program/project cross-functional teams to provide biocompatibility assessments, strategy and deliverables in compliance with global regulatory requirements such as ISO 10993. EU MOR, REACH, RoHS, and Prop 65 as well as other global regulatory requirements.
• Plan and manage the impact assessment of manufacturing, supplier, and material changes to medical devices and new products with patient contacting components to ensure biological safety and product sustainability.
• Identify and assess business/technical project risks and recommend/influence contingency plans for risk mitigation. Apply technical expertise to solve complex biocompatibility problems as related to the ISO 10993 standards and regulatory authority requirements for product safety.
• Support the creation and defense of submissions to global Regulatory Authorities.
• Collaborate and clearly communicate with internal and external stakeholders (e.g., Board Certified Toxicologists and Contract Research Organizations (CROs) to ensure appropriate planning and execution of risk assessments and required testing.
• Review, interpret, and summarize raw data from external stakeholders on reports and documents and biological risk assessments using sound scientific principles.
• Ensure that testing is conducted per appropriate GLP to meet all international & domestic test requirements according to ISO, FDA, EU MDR, GLP, MDSAP, and APAC countries.
• Conduct quantitative risk assessments on chemical characterization profiles as a part of biocompatibility evaluations.
• Support on-site and off-site Regulatory Authority audits to for product that may be sold in worldwide markets.
• Maintain biocompatibility assessment documents for each production. Ensure the assessment documents are in accordance with the latest version of the standards.
  
  

Skills For Success

• Master's degree or 3+ years of experience with a PhD degree in biology, biochemistry, toxicology, analytical chemistry or materials science.
• 5+ years of experience as a functional expert in the principles of Biocompatibility Risk assessment.
• Expert in US and global regulations and requirements for biocompatibility and safety testing, particularly ISO 10993-1, 10993-17 and 10993-18
• Knowledgeable of applicable ASTM, ISO, FDA, EN, Japan, and APAC standards
• Knowledgeable of pertinent sections of REACH, the EU MDR, and Proposition 65 (hazardous substances regulations) as well as ICH and FDA Guidance Documents (e.g., Threshold of Toxicological Concern and Use of ISO 10993-1, etc.)
• Experience in pre-clinical science/biocompatibility testing in medical device, pharmaceutical, or biotechnology industries.
• Demonstrated research effectiveness; patents and/or publication in peer review journals, etc. is a plus.
• Effective project management and communications skills in a dynamic, matrixed, geographically diverse business environment to meet deadlines and deliver on commitments.
• Effectively manages relationships and projects with external stakeholders (e.g. Contract Research Organizations).
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Proficient with statistics and Microsoft suite of office applications.