Position Summary

The Biocompatibility Specialist will be responsible for Biocompatibility, Extractable & Leachable (E&L) and Biocompatibility Testing report activities, which includes classification of the product category, interpretation of the applicable regulatory guidance and standards for each product category and developing a robust Biocompatibility and E&L test panel to ensure compliance with national and international regulatory requirements. Additionally, the Biocompatibility Specialist shall work as a liaison between contract research labs and ICU Medical and shall co-ordinate test sample preparation, testing, assessing test data, and writing/reviewing biocompatibility, E&L assessments, and summary reports for regulatory submission package.

Other responsibilities include working closely with Core team leader in understanding the stakeholder needs and collaborating with cross-functional team members in understanding test sample/corner case selection criteria for products/product families to be tested in order to increase efficiency in testing. Responsibilities also include staying up-to date with changes to applicable international standards and regulations that apply to medical devices and IV Solutions (Large Volume Parenterals). This position is responsible for coordinating and following procedures and protocols at ICU Medical that are pertaining to biocompatibility and general Design Controls.

Essential Duties & Responsibilities

• Deliver biocompatibility assessments and biocompatibility evaluation plans and reports complying with applicable biological evaluation standards and FDA/ISO guidance documents within a risk-based framework.
• Analyze biocompatibility test results to determine adequacy of data to meet requirements for the biological effects, and utilize problem solving skills and technical knowledge to troubleshoot unexpected result
• Perform and assist gap analysis of external standards, regulatory requirements and guidance associated with biological safety evaluation
• Liaise with internal resources (development, regulatory, quality, clinical and manufacturing) and external resources (e.g. Contract Research Organizations (CROs)) to develop and coordinate test strategies and ensure appropriate execution of required testing in compliance with internal SOPs, recognized standards, and applicable global regulatory requirements (e. g. FDA, ISO, MHLW, and NMPA)
• Coordinate biological and chemical clearance for use studies for new and modified devices and parenteral drug products and related manufacturing processing aids
• Act as liaison between ICU Medical design engineers and contract test laboratories conducting Biocompatibility tests
• Generate verification protocols, verification summary reports in support of Biocompatibility projects.
• Aid in development of internal policies and procedures regarding biosafety compliance requirements
• Develop Biocompatibility/ E&L test panels based on applicable Regulatory and International standards for compliance.
• Act as ICU Medical Representative to Industry Biosafety/Biocompatibility-related standard committees
• Working closely with Core team leader in understanding the project needs and collaborating with cross-functional team members to appropriately establish test sample/ corner case selection criteria for products/ product families to be tested in order to increase efficiency in testing.
• Support and execute audits of contract laboratories
• Perform material searches in various databases for historical biocompatibility studies
• Support responses to Customer queries on biocompatibility issues
• Support responses to Regulatory queries for historical biocompatibility reports to support International Registrations
• Perform/coordinate biological and chemical testing in response to Marketing and customer requirements and in light of adverse patient reports
• Ensure that the appropriate external biocompatibility testing laboratories are qualified to support internal testing volumes and projects.

Knowledge, Skills & Qualifications

• Knowledge of chemistry and/or biology, basic understanding of medical device manufacturing processes, large volume parenteral manufacturing processes, and sterilization methods and their effects on the biocompatibility of polymeric biomaterials used in the medical applications. Ability to interpret medical device and/or pharmaceutical material biosafety standards and create Biocompatibility test panels for internal customers. Ability to multi-task and coordinate competing priorities.

Education and Experience

• Bachelor’s degree in Life Sciences (Biology, Biochemistry, Biomedical, Chemistry, or Materials Science) or a closely related scientific discipline with applicable experience.
• Master’s degree in Life Sciences (Biology, Biochemistry, Chemistry, Pharmacology, Toxicology, or Material Science)
• 3 years of experience required; 5 years of experience preferred

Minimum Qualifications

• Must be at least 18 years of age

Travel Requirements

• Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

• This job operates in a professional office environment and routinely uses standard office equipment.
• Must be able to occasionally move and lift objects of up to 25 lbs. - carrying boxes of test samples for shipping to the contract labs.

Salary Range: $72,000-$96,750

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.