Engineer III

Roles& Responsibilities

• The Combination and Medical Device Products Consumable Device US team is expanding its support for on-market devices.
• This role will be responsible for on-market change execution, product lifecycle management, and manufacturing support specific to the product design.
• Proficiency with medical device/pharmaceutical DHF traceability is required.
• Proficiency with test execution, deviation reporting and management, data review, and report writing is required.
• Experience with medical device EU and/or FDA regulations is required.
• In addition to product support, you will also be responsible for 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.)
• Exceptional written and verbal communication skills, and 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.