AirLife · 1 month ago
Staff Project Engineer
Grand Rapids, MI
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expSunMed LLC, through its AirLife division, is dedicated to improving the quality of every breath and is a premier manufacturer of breathing consumables. The Staff Project Engineer will manage improvement projects for existing products and implement product line extensions, coordinating with manufacturing primarily based in China.
Health CareMedicalMedical Device
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
Qualification
Required
Knowledge of the design and development processes used for medical devices
Experience with manufacturing processes for plastic components such as injection molding knowledge
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
Preferred
Experience in a medical device, pharmaceutical, or plastics manufacturing facility
Company
AirLife
AirLife is a healthcare company that specializes in anesthesia and respiratory care products.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Hendrik Struik
Chairman and CEO at AirLife
Caitlin Anderson
Chief Administrative Officer, General Counsel, & Corporate Secretary
Recent News
2025-05-01
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