Summary:
A global Medical Devices company based in Cork is seeking a Process Excellence Manager. This is a key role that will lead the Process Capability workstream within the Manufacturing Excellence CoE, deploying proven practices globally across sites and defining operating standards to embed ways of working. This role will also have responsibility for the deployment of Six Sigma, building people capabilities within teams. The role will be accountable for the sites achieving savings targets and will be required to work closely with the Process Excellence teams based on the sites.

Responsibilities:

• Develop a multi-site process capability strategy to reduce process variability delivering improvements in quality and value.
• Define future system requirements relating to data collection, visualization and analytics.
• Lead a team to build a portfolio of projects across our manufacturing sites to deliver business critical results.
• Develop and execute a roadmap with focused workstreams in-line with the Engineering strategic objectives.
• Work with the sites to develop business cases for investment in new project / initiatives.
• Ensure Six Sigma principles are embedded into continuous improvement activities and ways of working.
• Engage and manage relationships with business partners to ensure the successful adoption of identified solutions across the Business.
• Awareness of Regulatory aspects in relation to the current and future processes.
• Identify capital and budget requirements for Continuous Improvement Projects.
• Ensure that all projects are run cost efficiently and deliver reliable, robust and capable processes.
• Promote a quality-focused culture within the team, ensuring alignment to GMP and the Quality System.
• Provide timely and accurate reporting on project activities to the project sponsors, partners and senior management.
• Implement Program and Project Management Best Practices within the Process Excellence Function.
• Prioritize projects in line with business requirements & strategic objectives.

Qualifications & Experience:

• 10+ years experience and a Degree in Science, Engineering or a related Discipline
• Previous project management & people management expertise across a diverse and multifaceted environment.
• Six Sigma Black Belt Certified.
• Desirable: Track record collaborating with Operations and Quality functions to enable the delivery of complex products and processes.
• Six Sigma Master Black Belt.
• Strong influencing skills - Excellent communication skills (written and oral).
• Problem solving skills – To assist in maintaining project progress and on design issues.

Project Engineer with Packaging experience required for a Medical Devices client here in Cork. Working on the introduction of a suite of new products you will own particular process steps or technologies to ensure that the safety and quality of the process. You and the team will develop, qualify and launch the new manufacturing process.

This can be either a permanent appointment with an attractive salary and benefits package or a contract role with a competitive daily rate.

About the Job:

• Process development and value engineering including PFMEA
• Process Characterisation
• Process Qualification/Validation
• Planning of key deliverables into action plans with the help of the Project Manager
• Regular reporting on the status, performance and risks of your process / technology
• Developing packaging technologies and processes
• Participate in DFM reviews with Design Team to minimize lifecycle cost
• Minimize Environmental and Health & Safety effects of your work
• Adhere to the company’s procedures as detailed in the SOP manual
• Support Regulatory Affairs with product submissions

About You:

• Third level Engineering degree or similar discipline.
• Significant experience in product / process development with Class II / III medical devices or another regulated environment.
• Self-motivated, with focus on Quality, Delivery and Cost.
• Proven Root Cause analysis and problem-solving techniques 
• Exposure to Project Management
• Certified Six Sigma qualifications.
• Knowledge of anatomy and physiology
• Experience in cleaning and packaging processes and technologies

For more info give me a call on 087 3618142 or send your CV for consideration.

All potential candidates must hold an EU Passport or Stamp 4 Visa.

• Lead as Technical SME the Foundry Scrap Reduction Project, by working with project teams to review and challenge internally developed processes, specifications, instructions, and test methods.
• To provide direction to team members and other junior foundry personnel for the duration of this project.
• To develop an end-to-end project plan, update, maintain and report on all technical aspects/developments around the various strands of the Scrap Reduction project, including but not limited to carrying out various phases of the project, executing plans, materials work and other experimental outputs, from a technical/execution perspective.
• Direct technical project at Cork manufacturing site and/or with suppliers of Casting Raw Materials.
• Support the development of long-term strategy for developing and supporting Scrap Reduction related technologies, conduct risk assessments and lead detailed product / process design reviews.
• Assist with implementation of cost-effective investment casting material-related manufacturing solutions to drive engineering efficiencies at internal foundries and with external suppliers.
• Design, develop and conduct feasibility studies to assess current casting technologies and methods, with view to develop process and cost improvements.
• Develop creative casting qualification methodologies for new product and apply appropriate statistical and validation techniques based on overall risk.
• Contribute to the execution of Process Excellence initiatives directed toward Design Excellence of new products, as well as Lean Six Sigma of both new and existing processes & products, including but not limited to safety and ergonomic improvements, quality improvements, cost reductions and productivity improvements.
• Provide technical support for equipment design and development, manufacturing technical support, new product introduction and process improvement initiatives with responsibility for assisting with project execution and site partner alignment.
• Support process optimization, root cause analysis and scrap reduction activities related to casting material processes and identify appropriate resources and technical requirements for materials development sub-projects.
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
• Determine and validate the effectiveness of these techniques from previously implemented solutions/improvements.
• Develop business cases for new casting technology introduction and provides recommendations to the plant’s technology strategy while participating in collaborations with site Process and Projects Engineering teams.
• Ability to produce high quality and accurate Project work and deliverables, in a timely manner to meet the project timelines.
• Ensure that Company quality standards are always observed and maintained.
• Drive awareness in good manufacturing practices (GMP), ISO9001, IS013485 and ISO 1400, as required.
• Ensure that the specified procedures, process and systems are correctly executed by the foundry team, by ensuring that the quality system is fulfilled with the appropriate corrective and preventive actions identified.
• Ensure that all health, safety and environmental, industrial hygiene, environmental and labor regulatory requirements are fulfilled.

• Graduate in Engineering (required)
• Post-Graduate in Engineering (preferred)

• Advanced experience in Foundry manufacturing engineering, with specific experience in Ceramics processes and slurry tank processing troubleshooting, is a fundamental requirement
• Significant experience working in a regulated manufacturing environment (pharma, medical device, automotive, aerospace, etc.)
• Advanced field experience working in Ceramic castings or equivalent (die casting, Sand casting, direct metal injection etc.)
• Statistical and problem-solving engineering expertise (Six Sigma, SE or A3) - Six Sigma Green or Blackbelt certified.

• Good experience in leading complex Foundry improvement projects, working with multi-functional teams.
• Experience on new equipment (foundries and ancillary equipment – (Automation/Robotics) and or product introduction (NPI) experience
• Knowledge on mold tooling design / repair (ceramics, die casting, etc.)
• Experience with process, equipment and product validations (IQ, OQ & PQ’s)
• Basic understanding of regulatory requirements for the manufacturers of medical devices
• Proficiency with the use of solid modelling, solidification simulation and statistical analysis software, would be desirable.
• Familiar with PFMEA/DFMEA’s, TMV’s, Risk Assessments, Control Plans, including Validation and implementation activities and deliverables.

My client is a leading Irish multi-discipline Engineering & Project Management Company with offices in Dublin and in Cork. Established 30 years ago, the company provides services to clients in the Industrial, Government Agency, Educational, and Tourism & Leisure sectors. During this period, it has established a blue-chip listing of clients which the company continues to serve. Multiple projects have been successfully completed in the High Technology Biopharma, Medical Devices, Process and Data Centre sectors along with significant investments in the Educational, Government Agency, and Tourism & Leisure areas.

The company is now embarking on to the next level of expansion and in this light is planning to recruit a Director of Process Engineering and Cork Operations, based in their Cork office.

Job responsibilities:

• Responsible for all Process Engineering output of the company 
• Process Engineering resource allocation including mentoring and monitoring of all Process Engineers
• Project management of selected projects
• Assist business development of Pharma/Biotech/Medical Devices and general process projects including identification and targeting of same
• Member of Board of Management including attendance at all weekly management meetings
• Provide input into company business strategy
• Proactive involvement in professional activities organized by ISPE, IChemE, and Engineers Ireland
• Responsible for building up a sustainable business base in the Cork Office

Job requirements:

• 15+ years' experience
• Chartered Chemical Engineer or possessing equivalent experience
• The knowledge and experience necessary to take a project from initial concept design through to construction and client handover
• Very good technical skills in all aspects of process design
• Capable of working on a number of simultaneous projects with different clients, priorities, and design requirements
• Previous experience of leading a Design Team would be an advantage
• Capable of representing the company effectively with clients at project meetings and at presentations
• Ability to deliver on time and meeting tight deadlines
• Motivated and enthusiastic team player with a pro-active and flexible approach to work

Candidates must be highly motivated, commercially astute, possess excellent team leadership and communication skills, and enjoy a challenging career. The successful candidate will report directly to the Managing Director.

A first-class remuneration package will be on offer reflecting the seniority of the position and will be based on the relevant experience, qualifications, and potential of the successful candidate.

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@sigmar.ie

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