Job Title: Process Development Engineer
We are seeking a highly skilled and motivated Process Development Engineer to join our team in Parkmore, Galway.
About Us
Our client is a medical device company dedicated to developing innovative solutions for heart support devices. These devices are used by interventional cardiologists to stabilize patients with acute heart failure or those undergoing high-risk coronary procedures.
Job Description
The successful candidate will be responsible for supporting the development and implementation of manufacturing and assembly processes associated with our pVAD catheter. This includes design feedback and input as well as working closely with suppliers of catheter components.
* Responsibilities:
* Develop manufacturing processes, materials, and methods as part of the product development team.
* Design, specify, procure, and qualify process fixtures and equipment.
* Develop Work Instructions and other supporting documentation for manufacturing processes.
* Execute process characterization and validation activities.
* Become a technical expert in the assembly and manufacture of our products, providing technical guidance to other team members.
* Build Quality into all aspects of work by maintaining compliance with all quality requirements.
* Work with internal cross-functional teams and contract manufacturers or design firms to ensure system design, architecture, and verification/validation meet design input.
* Support cleanroom setup, fit-out & validation.
* Evaluate relevant process & manufacturing technologies and strategically identify opportunities to implement them.
Requirements
To be considered for this position, candidates must have:
* A minimum of three years of medical device development experience and either 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; experience in large calibre delivery systems is an advantage.
* Product and process development, and new product introduction skills in medical devices are a must, particularly fixture and equipment design & specification, validation of processes and process equipment, and development of Work Instructions and Calibration & Maintenance activities for manufacturing processes.
Estimated Salary:
$120,000 - $150,000 per annum, depending on experience.