Engineer III

Roles & Responsibilities

• On-market change execution
• Product lifecycle management
• Manufacturing support specific to product design
• Proficiency with medical device/pharmaceutical DHF traceability
• Proficiency with test execution, deviation reporting and management, data review, and report writing
• Experience with medical device EU and/or FDA regulations
• Standardizing and simplifying activities within the team to enable more efficient development and marketed product support

Education & Experience

• Bachelor of Science degree with 3+ years of experience in medical device or pharmaceutical development roles
• Graduate degree in a technical or scientific field
• Prior experience in consumable medical device/pharmaceutical development
• Medical device/pharmaceutical development, office, and laboratory settings
• Design History File product lifecycle management experience
• Engineering degree in bioengineering, chemical engineering, or mechanical engineering
• On-market supplier changes
• Knowledge of applicable global regulatory requirements and industry standards (MDR requirements, ISO 13485, ISO 14971, ISO 10993, etc.)

Skills

• Exceptional written and verbal communication skills
• The ability to clearly articulate development challenges and implementation strategies to stakeholders across a broad range of functional groups at all levels of the organization, including external vendors