Engineer III
Katalyst Healthcares and Life Sciences
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.
- 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.
Vacancy posted 2 days ago
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