Manufacturing Operations Specialist
We are seeking a seasoned Manufacturing Operations Specialist to play a pivotal role in establishing, optimizing, and scaling manufacturing operations for a next-generation medical device.
* Leverage expertise in process development, optimization, and validation to drive business growth and quality excellence.
* Prioritize collaboration with cross-functional teams, including R&D, Quality, and Supply Chain, to support New Product Introduction (NPI) and design transfer into manufacturing.
To be successful in this role, candidates will need to possess:
* Bachelor's Degree in Engineering or related field.
* Minimum 3+ years' experience in medical device manufacturing or operations engineering.
The ideal candidate will have a deep understanding of manufacturing process controls, root cause analysis, and risk management, as well as hands-on experience with process validation, equipment qualification, and documentation within a regulated environment.
Skillset Highlights:
* Process development and optimization.
* New product introduction and design transfer.
* Maintaining compliance with regulatory requirements.
* Fostering strong relationships with cross-functional teams.
This is an exceptional opportunity for a motivated professional to make a meaningful impact on the success of our organization.