Knowledge of fda regulations and quality management systems
This role focuses on performing general engineering methods and tools while developing advanced technologies within the medical device industry
Job Summary
This role focuses on performing general engineering methods and tools while developing advanced technologies within the medical device industry.
The engineer will lead initiatives to drive innovation and continuous improvement by championing the Integer Production System and its five focus areas.
Success in this position requires adherence to strict safety, environmental, security, and FDA regulatory requirements while collaborating with operations to resolve complex issues.
Matching Summary
This role focuses on performing general engineering methods and tools while developing advanced technologies within 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
Experience with Lean methodologies and continuous improvement
Root cause analysis and failure analysis skills
Value stream mapping and workplace organization (5S)
Total productive maintenance and standardized work
Nice-to-have
Proactive insight into technical challenges
Strong written and oral communication skills
Ability to work independently with occasional guidance
Positive can-do attitude in high-energy environments
Experience with 5 Sigma quality journey
Collaborative mindset across cross-functional teams
Key Requirements
Minimum Bachelor's degree in engineering
At least three years of relevant experience
Functional understanding of Quality Management Systems
US citizenship or work authorization required for applicants