Staff Product Design Engineer

AirLife•Grand Rapids, MI

74d•Remote

About The Position

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.

Requirements

Knowledge of the design and development processes used for medical devices.
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.
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).
5-10+ years of post-graduate experience in an engineering position.
Bachelor’s degree in engineering, manufacturing, industrial, or mechanical engineering required.

Nice To Haves

Experience with manufacturing processes for plastic components such as injection molding, extrusion, ultrasonic welding knowledge is preferable.
Experience in a medical device, pharmaceutical, or plastics manufacturing facility preferred.

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.
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.