Process Engineer
We are seeking an experienced manufacturing process developer to support the development and implementation of production processes associated with our medical devices. The successful candidate will have hands-on knowledge and experience in both the development of cardiovascular devices and the processes required to manufacture them.
Responsibilities:
* Develops manufacturing processes, materials, and methods as part of the product development team.
* Designs, specifies, procures, and qualifies process fixtures and equipment.
* Develops work instructions and other supporting documentation for manufacturing processes.
* Executes process characterization and validation activities.
* Provides technical guidance to other team members on the assembly and manufacture of products.
* Maintains compliance to all quality requirements by building quality into all aspects of work.
* Collaborates with internal cross-functional teams and external partners to ensure system design, architecture, and verification/validation meet design input.
* Supports cleanroom setup, fit-out, and validation.
* Evaluates relevant process and manufacturing technologies to identify opportunities for implementation.
* Executes project plans, tasks, and deliverables to meet project deadlines.
Required Qualifications:
* Minimum of three years of medical device development experience and a primary or Master's Degree in a relevant engineering discipline such as polymer, mechanical, manufacturing, or biomedical engineering.
* Experience in fabrication and manufacture of catheter-based medical devices, with experience in large caliber delivery systems being advantageous.