Staff Project Engineer

SunMed Group Holdings, LLC dba AirLife•Grand Rapids, MI

20d

About The Position

This Staff Project Engineer 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.

Requirements

The ideal candidate for this position will have 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.
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).
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 knowledge is preferable.
Experience in a medical device, pharmaceutical, or plastics manufacturing facility preferred.

Responsibilities

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.
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.