Process Development Engineer

Process Development Engineer

Limerick - Hybrid Role

Company:
My client are a medical device company developing new and innovative invasive medical devices. As the Process Development Engineer, you will join an award winning Research and Development team focusing on the implementation of new projects and cutting edge devices.
Job Description:
Support the development and implementation of manufacturing and assembly processes associated with NPI, design feedback & input, as well as working with the suppliers key components. The PD Engineer will work closely with his/her counterparts responsible for device development and characterization, other development functions, and Quality.

The successful candidate will have be a self-starter, together with the required persistence and resourcefulness to succeed.

They will have hands-on knowledge and experience in both the development of Class III Medical 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 (e.g. calibration and maintenance) for manufacturing processes
• Executes process characterisation and validation activities
• Becomes a technical expert in the assembly and manufacture of our products, and provides technical guidance to other team members
• Builds Quality into all aspects of work by maintaining compliance to all quality requirement
• Works with internal cross-functional teams and contract manufacturers or design firms to ensure system design, architecture, and verification/validation meets design input
• Supports cleanroom setup, fit-out & validation
• Evaluates relevant process & manufacturing technologies and strategically identifies opportunities to implement them
• Executes project plans, tasks and deliverables.
• Manages time to meet project deadlines.
• Uses structured problem-solving techniques and statistical methods for data driven analysis and decisions Skills,
  Required Qualifications:
• Minimum of three years of medical device Process Development experience, and have either a primary or Master s Degree in a relevant engineering discipline such as polymer, mechanical, manufacturing or biomedical engineering.
• Hands-on knowledge and experience in both the development of Class III Medical Devices
• Experience in fabrication and manufacture of Medical devices
• Product and Process Development, and new product introduction skills in medical devices are a must.
• In particular:

• Fixture and equipment design & specification
• Validation of processes and process equipment
• Development of Work Instructions and Calibration & Maintenance activities for manufacturing processes

For immediate consideration please forward your CV together with a covering note outlining your relevant experience and your availability notice.