Process Engineer - Medical Devices

My client, a medical device company, is recruiting for a Process Engineer to join their team. This is a full time permanent position that would report to the Technical Manager.

This position would provide technical assistance to the Production Department in the form of process improvement, cost reduction, safety enhancement, and troubleshooting.

MAIN DUTIES/ RESPONSIBILITIES

• Participates in and/or leads Lean Six Sigma projects and initiatives.

• Writes, conducts, analyzes, determines and reports on new or modified equipment capabilities, qualifications (IQ/OQ/PQ), and validations.

• Conducts developmental runs and Commercialization qualification trial runs in conjunction with Research & Development (R&D) and PD functions.

• Manages the development of new package design and testing in conjunction with R&D and Marketing and communicates to the Process Engineering Lead the progress of these projects.

• Establishes Manufacturing Standard Operating Conditions (SOC) with the appropriate input from the Machine Operators, Supervisors and Technical personnel.

• Determines the need for, and justifies capital projects such as source, specifying new equipment and components by completing and routing Authorization for Capital Expenditure (ACE) form

• Assists the Product Engineer in the development of customer and internal specifications, including review and approval of Applications Review Forms (APPS).

• Performs Root Cause Analysis and Corrective Actions for Customer Complaints as assigned.

• Troubleshoots daily production and process problems, communicates with Plant Management Team, Supervisors, and Operators regarding run problems, investigates root causes, recommends, and implements corrective actions.

REQUIREMENTS

Education -Degree in Engineering (Mechanical, Chemical or Industrial preferred)

Specific training and Experience

• Strong project management and organizational skills and the ability to maintain projects.

• Ability to react quickly and logically to manufacturing problems.

• Ability to apply Six Sigma & Lean Manufacturing Tools

• One to three years previous process/manufacturing engineering experience in a high volume GMP environment ideally in Medical Devices.

• Knowledge and understanding of ISO Quality Management Procedures

• Experience of Vision System Support would be an advantage

For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671