Knowledge of fda regulations and quality management systems
The primary purpose of this position is to perform general engineering methods while developing advanced technologies in the medical device industry
Job Summary
The primary purpose of this position is to perform general engineering methods while developing advanced technologies in the medical device industry.
You will ensure customer expectations are met by adhering to strict safety, environmental, security, and FDA regulatory requirements.
This role requires embedding quality within the engineering discipline and contributing to the attainment of site Quality KPIs and a journey to 5 Sigma.
Matching Summary
The primary purpose of this position is to perform general engineering methods while developing advanced technologies in the medical device industry.
Skills & Requirements
Must-have
Bachelor's degree in engineering or related field
Three years of relevant engineering experience
Knowledge of FDA regulations and Quality Management Systems
Root cause analysis and failure analysis skills
Ability to work independently with occasional guidance
Nice-to-have
Positive can-do attitude in high-energy environment
Proactive insight into technical challenges
Strong written and oral communication skills
Experience with Lean Manufacturing principles
Collaborative team player mindset
Key Requirements
Bachelor's degree in engineering or related technical field
Minimum three years of relevant engineering experience
Functional understanding of Quality Management Systems (QMS)
U.S. citizenship or work authorization status not specified