Are you a Senior Manufacturing Engineer with experience in the Medical Device industry? Would you like to work for a multinational company based in Galway? This is a permanent, full time role, with excellent salary and benefits.
Senior Manufacturing Engineer - Medical Devices - Galway
Employer
Our client is a multinational medical device manufacturer who specialise in the development and manufacture of cardiovascular devices and implants.
Job Description
The primary function is to support manufacturing by improving product quality, line efficiency/process optimization, and manufacturing costs by evaluating new materials, processes and equipment.
They will facilitate and drive continuous improvement of technology/processes and are capable of utilizing a variety of statistical tools to validate process improvements.
Due to high volume of new equipment planned from the Automation group over the course of the coming year and beyond a process development engineer is required to fulfill the following primary functions:
Role & Responsibilities
Liaise with the Automation group during the development of new equipment in order to ensure input is provided on manufacturing related factors such as, throughput requirements, ergonomics, preventative maintenance, calibration,
Design for Validation, Design for Lean/Six Sigma, etc. at the early stages of equipment development.
Process development and process characterization using DOE techniques to ensure robust operating process parameters are established and a strong understanding of the equipment capabilities is gained.
Development of risk assessments (PFMEA’s) early in the equipment development cycle to ensure all potential risks are identified.
Process validation (IQ, OQ, PQ) associated with the new equipment introductions.
Work with the Automation group to ensure equipment drawings, manuals, spare parts, etc. are in place and controlled under
Quality System change control procedures.
Work with manufacturing technicians to ensure transfer of knowledge from the Automation group for all new equipment.
Evaluate current equipment/processes for sources of variation and sub-optimal capability and implement adequate process controls.
Responsible for identification and implementation of process related continuous improvement activities to improve product quality and increase Overall Equipment Effectiveness.
Demonstrate strong leadership and a clear identifiable work ethos within the team.
Engage with the appropriate personnel in the identification and resolution of Corrective/Preventative actions to address Quality,
Technical, and Manufacturing issues (Audit Actions, NCR’s, CAPA’s, etc.).
All employees are responsible for the Environmental and Health & Safety effects of the work that they perform.
Requirements:
Degree in Mechanical Engineering /Manufacturing Engineering.
Experience in a medical device industry for manual and semi-automatic processes.
Experience with equipment transfer/introduction and/or NPI.
Process development and process characterization experience utilizing statistical techniques including DOE.
Process validation experience (IQ/OQ/PQ etc.)
Experience in process/equipment risk assessments using Risk Management tools such as PFMEA.
Lean/Six Sigma experience. Data driven analysis with emphasis on statistical techniques.
Self-confident with drive to identify process and equipment issues and implement robust solutions in a timely manner.
Excellent analytical and problem solving skills, root cause analysis and risk assessments with a strong attention to detail.
Ability to work on own initiative.
Good interpersonal and communication skills with proven leadership abilities.
Package:
Permanent Full time position
€45K+ depending on experience
Healthcare
Life Cover
Defined Contribution Pension Scheme
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Biotech / Pharma / Medical Device Jobs in Ireland
Jobs in Ga
Are you a Senior Manufacturing Engineer with experience in the Medical Device industry? Would you like to work for a multinational company based in Galway? This is a permanent, full time role, with excellent salary and benefits.
Senior Manufacturing Engineer - Medical Devices - Galway
Employer
Our client is a multinational medical device manufacturer who specialise in the development and manufacture of cardiovascular devices and implants.
Job Description
The primary function is to support manufacturing by improving product quality, line efficiency/process optimization, and manufacturing costs by evaluating new materials, processes and equipment.
They will facilitate and drive continuous improvement of technology/processes and are capable of utilizing a variety of statistical tools to validate process improvements.
Due to high volume of new equipment planned from the Automation group over the course of the coming year and beyond a process development engineer is required to fulfill the following primary functions:
Role & Responsibilities
Liaise with the Automation group during the development of new equipment in order to ensure input is provided on manufacturing related factors such as, throughput requirements, ergonomics, preventative maintenance, calibration,
Design for Validation, Design for Lean/Six Sigma, etc. at the early stages of equipment development.
Process development and process characterization using DOE techniques to ensure robust operating process parameters are established and a strong understanding of the equipment capabilities is gained.
Development of risk assessments (PFMEA’s) early in the equipment development cycle to ensure all potential risks are identified.
Process validation (IQ, OQ, PQ) associated with the new equipment introductions.
Work with the Automation group to ensure equipment drawings, manuals, spare parts, etc. are in place and controlled under
Quality System change control procedures.
Work with manufacturing technicians to ensure transfer of knowledge from the Automation group for all new equipment.
Evaluate current equipment/processes for sources of variation and sub-optimal capability and implement adequate process controls.
Responsible for identification and implementation of process related continuous improvement activities to improve product quality and increase Overall Equipment Effectiveness.
Demonstrate strong leadership and a clear identifiable work ethos within the team.
Engage with the appropriate personnel in the identification and resolution of Corrective/Preventative actions to address Quality,
Technical, and Manufacturing issues (Audit Actions, NCR’s, CAPA’s, etc.).
All employees are responsible for the Environmental and Health & Safety effects of the work that they perform.
Requirements:
Degree in Mechanical Engineering /Manufacturing Engineering.
Experience in a medical device industry for manual and semi-automatic processes.
Experience with equipment transfer/introduction and/or NPI.
Process development and process characterization experience utilizing statistical techniques including DOE.
Process validation experience (IQ/OQ/PQ etc.)
Experience in process/equipment risk assessments using Risk Management tools such as PFMEA.
Lean/Six Sigma experience. Data driven analysis with emphasis on statistical techniques.
Self-confident with drive to identify process and equipment issues and implement robust solutions in a timely manner.
Excellent analytical and problem solving skills, root cause analysis and risk assessments with a strong attention to detail.
Ability to work on own initiative.
Good interpersonal and communication skills with proven leadership abilities.
Package:
Permanent Full time position
€45K+ depending on experience
Healthcare
Life Cover
Defined Contribution Pension Scheme
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Biotech / Pharma / Medical Device Jobs in Ireland
Jobs in Ga
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
