Job Title: Process Development Engineer for Medical Device
About the Role:
We are seeking a highly skilled and experienced Process Development Engineer to join our team. The successful candidate will develop and implement manufacturing processes for medical devices, design feedback & input, and work with suppliers.
Key Responsibilities:
* Develops manufacturing processes, materials, and methods.
* Designs, specifies, procures, and qualifies process fixtures and equipment.
* Develops Work Instructions and supporting documentation.
* Executes process characterisation and validation activities.
* Becomes a technical expert in assembly and manufacture of products.
* Ensures Quality is built into all aspects of work by maintaining compliance to quality requirements.
* Works collaboratively with internal cross-functional teams and external partners.
* Sets up cleanroom, fit-out & validation.
* Evaluates relevant process & manufacturing technologies.
* Manages project plans, tasks, and deliverables.
Requirements:
* Minimum of three years of medical device development experience.
* Primary or Master's Degree in engineering discipline such as polymer, mechanical, manufacturing or biomedical engineering.
* Experience in fabrication and manufacture of catheter based medical devices.