Staff Product Design Engineer

Job Description

Job Description

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 within the AirLife portfolio. The Staff Product Design Engineer acts as the subject matter expert related to product design intent for their assigned product families. This position supports all design and manufacturing activities within these product families.

POSITION QUALIFICATIONS

Knowledge, 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, extrusion, ultrasonic welding knowledge is preferable.
• Working knowledge of solid modeling (Solid Works preferred) and Design for Six Sigma.
• Demonstrated ability to make sound decisions under pressure.
• High level of ownership and pride in work.
• Demonstrated success working with a global manufacturing supply base.
• 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:

• 5-10+ 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:

• As the business needs.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Create and modify existing product specifications based on ISO standards, and customer requirements.
• Oversee product improvement projects and manage project timelines while interacting with external and internal resources.
• Review, modify, and approve verification/validation documents per FDA guidelines
• Author design verification protocols and reports throughout the design controls process.
• Work with Marketing and customers to create requirements and specifications.
• 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.
• Supports Customer Complaints, Non-conformances, CAPA, & SCAR activities.
• Train associates with work techniques, and skills required to perform product assembly or processing.
• Coordinate, prepare, and test products for the preparation of Device Master Records (DMR’s).
• Assist in maintaining Food & Drug Administration (FDA), Good Manufacturing Practices (GMP), and ISO Compliance.

OTHER RESPONSIBILITIES

• Uphold and embody AirLife’s values in all aspects of work.
• 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.

Please note: The responsibilities outlined above are not exhaustive and may evolve over time. The role holder may be required to undertake additional duties as reasonably expected to meet the needs of the company.