Bachelor's degree in engineering or related technical field
Three years of relevant engineering experience
Knowledge of fda regulations and quality management systems
The primary purpose of this position is to perform work involving general engineering methods while developing advanced technologies in the medical device industry
Job Summary
The primary purpose of this position is to perform work involving general engineering methods while developing advanced technologies in the medical device industry.
You will ensure customer expectations are met by evaluating existing products and processes for failure analysis and potential improvements using standard data analysis practices.
This role requires embedding quality within the engineering discipline by assuring adherence to the Quality Management System and contributing to the journey to 5 Sigma.
Matching Summary
The primary purpose of this position is to perform work involving general engineering methods while developing advanced technologies in the medical device industry.
Skills & Requirements
Must-have
Bachelor's degree in engineering or related technical field
Three years of relevant engineering experience
Knowledge of FDA regulations and Quality Management Systems
Ability to work independently with occasional guidance
Functional understanding of QMS documentation tasks
Nice-to-have
Proactive insight into technical challenges
Positive can-do attitude with belief failure is not an option
Calm demeanor in high energy production environment
Strong written and oral communication skills
Experience with continuous improvement methodologies
Key Requirements
Bachelor's degree in engineering or related technical field
At least three years of relevant experience
7+ years experience if no bachelor's degree
Functional understanding of Integer Quality Management Systems