Manufacturing Engineer II - PMO

HERO Recruitment; Galway; On-site; EUR 60,000 - 85,000; Full time

Job summary

HERO Recruitment is recruiting on behalf of a medical device manufacturer in Galway, Ireland, for a product and process engineering role focused on delivering quality, safety and cost improvements. You will provide technical leadership and drive Lean initiatives across multiple teams and sites.

You will apply structured methodologies, validate processes, and collaborate with quality, engineering and manufacturing to meet production goals while maintaining GMP compliance.

Qualifications

• HETAC Level 8 qualification in engineering or a relevant field.
• 2+ years' experience in engineering function, preferably medical devices or regulated environment.
• Process Validation (OQ/PQ).
• Knowledge of MES, SAP or Windchill is advantageous.
• Windchill CN access is beneficial.
• Good technical capabilities, communication, teamwork and initiative.
• Project Management experience is advantageous.

Responsibilities

• Provide technical leadership on product and process issues.
• Lead technical improvement under the team’s VIP program.
• Lead process improvement programs across people, service, quality and cost.
• Apply structured and systematic methodologies.
• Liaison with quality and engineering internally and externally.
• Participation, where appropriate, in phase reviews and NPE meetings for new products.
• Ongoing manufacturing support to meet objectives of quality, output and cost.
• Maintain a valid capacity model with the line Supervisor and plan capital.
• Provide leadership on Lean initiatives.
• Develop and implement GMP-compliant documentation with the team.
• Project planning for major projects and product/process transfer.
• Evaluate new equipment/processes/chemicals for environmental impact.
• Contribute to other projects as assigned.
• Demonstrate commitment to patient safety and product quality.
• Understand and comply with quality system regulations.
• Develop themselves and team members.
• Manage capacity/sustaining projects across sites and teams.

Skills

Technical leadership

Communication skills

Teamwork abilities

Initiative

Project Management

Education

HETAC Level 8 qualification in engineering or a relevant field

Tools

MES

SAP

Windchill

Windchill CN access

Job description

Job Purpose

Provides daily support of products, processes, materials, and equipment in order to achieve production unit goals (i.e., People & Safety, Quality, Service, NPE, Cost & Productivity).

Key Responsibilities

• Providing technical leadership on product and process issues.
• Leading technical improvement under the team’s VIP program.
• Lead process improvement programs across people, service, quality and cost dimensions.
• Apply structured and systematic methodologies.
• Liaison with quality and engineering both internal to the plant and externally within the corporation.
• Participation, where appropriate, in the phase review process and the NPE meetings with respect to new products.
• Ongoing manufacturing support in order to help the team meet its business objectives of quality, output and cost.
• Maintain a valid capacity model in co-operation with the line Supervisor and conduct adequate advance planning for required capital.
• Provide leadership on Lean initiatives.
• Development and implementation of appropriate supporting documentation, which complies with GMP in conjunction with the other team members.
• Project planning, in detail, in support of major projects, product/process transfer etc.
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Responsible for other projects as assigned by the company.
• Demonstrate a primary commitment to patient safety and product quality.
• Understands and complies with all the regulations governing the quality systems.
• Develop themselves and team members.
• Manage delivery of capacity/sustaining projects while focusing on quality, output and cost.
• Self-reliant individual capable of managing timelines, and multiple projects across different sites, and organizational teams.

Qualifications & Experience

• HETAC Level 8 qualification in engineering or a relevant field, with relevant experience
• A minimum of 2 years’ relevant experience working in Engineering function, ideally within the Medical Device industry or another highly regulated environment.
• Process Validation (OQ/PQ)
• Knowledge of MES, SAP, Windchill is advantageous.
• Fast Track, and Full Track Windchill CN access and experience is beneficial.
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Project Management experience is advantageous.