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.