Manufacturing Engineer - PMO

HERO Recruitment; Connacht; On-site; EUR 50,000 - 70,000; Full time

Job summary

HERO Recruitment presents an engineering role in a medical device manufacturing environment in Ireland's Connacht region. The role focuses on daily product, process, and equipment support to meet GMP standards and production goals.

You will provide technical leadership, lead Lean and process-improvement initiatives, and collaborate with quality and engineering teams to ensure quality, output, and cost objectives are achieved. A background in regulated manufacturing is essential.

Qualifications

• HETAC Level 8 qualification in engineering or a relevant field and relevant experience.
• 2 years’ relevant experience in Engineering, ideally in Medical Device or highly regulated environments.
• Equipment installation and qualification.
• Process Validation (OQ/PQ).
• Knowledge of MES, SAP, Windchill is advantageous.
• Windchill CN access is beneficial.
• Strong technical capabilities and good communication within teams.
• Project Management experience is advantageous.

Responsibilities

• Provide technical leadership on product and process issues.
• Lead technical improvement under the VIP program.
• Drive process improvement across people, service, quality and cost.
• Apply structured and systematic methodologies.
• Collaborate with quality and engineering internally and externally.
• Participate in phase reviews and NPE meetings for new products.
• Support manufacturing to meet quality, output and cost objectives.
• Plan capacity with line supervision and manage capital planning.

Skills

Technical leadership

Process improvement

Lean initiatives

Cross-functional collaboration

Project management

Education

HETAC Level 8 in engineering

Tools

MES

SAP

Windchill CN

Job description

Our Mission:

We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to the healthcare professionals who provide their care.

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.
• Equipment installation & qualification
• 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.