COMPANY DESCRIPTION

At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us!

POSITION SUMMARY

The Biocompatibility Specialist role will be a part of the AirLife engineering team. This role reports to the Director of Engineering. The ideal candidate will have a strong expertise in medical device biocompatibility requirements and testing assuring our medical devices comply with global regulatory agency requirements, and having in depth knowledge of standards relating to biocompatibility requirements and testing.

POSITION QUALIFICATIONS

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.

Knowledge:

• Knowledge of standards relating to biocompatibility requirements and testing such as ISO 10993, ISO 18562, ISO 14971, etc.
• Basic understanding of project management.

Skills & Abilities:

• Excellent communication skills (written and verbal)
• Expert in US and global and country specific regulations (e.g., EU, China, MDSAP) and requirements for biocompatibility and safety testing, particularly ISO 10993 and ISO 18562 and related CDRH guidance.
• Ability to work in highly matrixed and geographically diverse business environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes, and meets deadlines in a timely manner
• Strong Organizational and follow-up skills, as well as attention to detail

Level of Experience:

• The position requires a minimum of 3 years of experience in Biocompatibility.
• Experience working with regulations and requirements, especially FDA and the EU Medical Device Directives (MDD) and Medical Device Regulations (MDR)

Level of Education:

• The position requires a Master or PhD degree in biology, biochemistry, toxicology, analytical chemistry or materials science, preferably with a specialization relating to medical devices.

Travel:

• As required based upon program and project needs.
• 1-2 days per quarter on average.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The core tasks, duties, and responsibilities that must be performed on the job.

• Serve as a biocompatibility subject matter expert (interpret data and define qualification strategies for new or modified devices or processes).
• Interfacing with appropriate internal and external resources to ensure engineering programs meet biocompatibility related regulatory and customer requirements.
• Collaborate with project teams to establish test recommendations and biocompatibility testing in compliance with current ISO 10993 and ISO 18562 standards and applicable guidelines.
• Planning and coordinating outsourced biocompatibility testing for new and in-process products including organizing logistics, guiding test labs and project teams ensuring successful outcomes. Testing including but not limited to: cytotoxicity, hemolysis, systemic toxicity, intracutaneous reactivity, sensitization testing, genotoxicity, chemical characterization, VOC and PM testing.
• Review and interpret test results for biocompatibility studies.
• Make appropriate recommendations and drive the implementation to improve the quality testing activities including product and safety related issues.
• Write, review, and approve protocols and reports pertaining to biocompatibility.
• Application of GLP regulations and ISO 10993 Biological Evaluation of Medical Devices.
• Create FDA clearance biocompatibility documentation.
• Create, review, and provide functional approval for project documentation.
• Identify and assess biocompatibility related project risks and recommend/influence contingency plans for risk mitigation in alignment with ISO 14971 Application of Risk Management to Medical Devices.
• Develop and maintain Global Standard Operating Procedures linked to our Quality Management System regarding biocompatibility.
• Develop departmental budget estimates for biocompatibility function.
• Comply with U.S Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, and task assignments.

OTHER RESPONSIBILITIES

• Focus on achieving our Company mission.
• Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
• Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
• Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
• Contribute to building and maintaining a positive team environment.
• Assure all policies and guidelines are implemented and followed.

QUALITY POLICY

At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance with Regulatory Requirements.

DEIA STATEMENT

At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.