Reporting directly to the VP of R&D lead combination device development from phase III clinical trials through transfer to manufacturing and global product launch

* This position requires hands-on experience authoring regulatory submissions.

* Collaborate with internal and external teams to design and implement strategies to scale up

* Support optimization and validation, maintain design history files, risk analysis, and FMEA.

* Investigate and manage change controls for new or updated designs

* Provide guidance on global quality system requirements

BS in Engineering discipline or equivalent, advanced degree preferred

Significant product development experience with Combination Product Development