Device Material Compliance Engineer

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 

Lead, plan, organize, and own the process of device material assessments by complying to the existing and emerging regulatory requirements for material selection and disclosure of new and existing medical devices. Responsibilities include setting the overall strategy and writing material declarations for regulatory compliance to REACH, RoHS, EU MDR, PROP 65, and other similar regulations. Other responsibilities include ownership of the company’s material database to be used for material replacement projects, biocompatibility evaluations, and material assessments. 

POSITION QUALIFICATIONS 

Knowledge, Skill & Abilities:  

• Knowledge and experience with global regulatory materials compliance for medical devices such as EU MDR, PROP 65, REACH, RoHS, Conflict Minerals, etc.
• Basic understanding of material science, specifically polymer science, is required. 
• Knowledge of medical device regulations and plastics manufacturing is preferred.
• Excellent oral and written communication skills at all levels in the organization. 
• Excellent attention to detail and information accuracy. 
• Ability to manage many projects at one time, while meeting timing expectations of the stakeholders. 
• Ability to effectively participate in a cross-functional team environment. 
• Proficient Microsoft Excel skills are required.

Level of Experience:  

The ideal candidate will have 1 - 3 years of experience in engineering, quality, or manufacturing of products in the medical device industry. Exposure to plastics manufacturing is preferred. Experience working collaboratively with cross-functional teams is a plus 

Level of Education:  

Bachelors Degree in Material Science, Chemistry, Engineering, Chemical Engineering, Toxicology, or a related field is preferred. 

Travel:  

Up to 10%. Occasional Overnight. 

ESSENTIAL DUTIES AND RESPONSIBILITIES 

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

• Gather, analyze, and maintain compliance data to support compliance to REACH SVHC, ROHS, Prop 65, PFAS and other applicable regulations.
• Develop and maintain full material compliance disclosures (including certifications and declarations for products) for Airlife products through working with suppliers and with cross functional teams.
• Build and maintain a material database considering regulatory compliance, existing biocompatibility testing data, and material properties to streamline the selection of future materials.
• Provide technical support and guidance on material compliance-related questions and issues.
• Involvement in early decisions for material selection to ensure the most efficient path forward for new materials and components.
• Setup and maintain a database of material compliance data collected from vendors and partners through the Assent compliance platform.
• Work with the cross functional team and supply base to obtain material information.
• Ensure on-time completion and submission of compliance statements to customers.
• Monitor and review regulation updates to ensure the most up-to-date information is on file.
• Lead the completion of benefit risk analysis documentation as applicable with the cross functional team.

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 to 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.