Job Description

Job Description

Position is a hybrid work schedule with preference for candidate to reside near Grand Rapids, MI or Alpharetta, GA location.

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

This position is responsible for managing improvement projects for existing products and implementing product line extension projects. Much of the company’s manufacturing is in China, so this position will be responsible for qualifying product changes and be the project manager for their site.

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: Acquired through education, certifications, training, experience.

**Skills & Abilities: **

• The ideal candidate for this position will have knowledge of the design and development processes used for medical devices.
• Experience with manufacturing processes for plastic components such as injection molding knowledge is preferable.
• Working knowledge of solid modeling (Solid Works preferred) and Design for Six Sigma.
• Demonstrated ability to make sound decisions under pressure.
• Displays effective written and verbal communication skills as well as active listening skills.
• Ability to interface effectively with health care professionals and medical device customers.
• Ability to travel both domestic and international (must have the ability to obtain a passport).

Level of Experience:

• 2-5 years of post-graduate experience in an engineering position.
• Experience in a medical device, pharmaceutical, or plastics manufacturing facility preferred.

Level of Education:

Bachelor’s degree in engineering, manufacturing, industrial, or mechanical engineering required.

Travel:

20%; although the amount of time required for this position will depend on specific project requirements.

ESSENTIAL DUTIES AND RESPONSIBLITIES

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

• Coordinate, prepare, and test products for the preparation of Device Master Records (DMR’s).
• Review, modify, and approve validation documents per FDA guidelines.
• Create and modify existing product specifications based on ISO standards, and customer requirements.
• Work with Marketing and customers to create requirements and specifications.
• Oversee product improvement projects and manage project timelines while interacting with external and internal resources.
• Perform/coordinate engineering product prototyping and testing.
• Manage projects including resource allocation with minimal assistance and direction.
• Identify and apply innovative approaches to solve complex problems.
• Drives decision through cooperation and commitment from cross-functional team members.
• Train associates with work techniques, and skills required to perform product assembly or processing.
• Assist in maintaining Food & Drug Administration (FDA), Good Manufacturing Practices (GMP), and ISO Compliance.

OTHER RESPONSIBLITIES

• 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.