Overview
 
 Our client is seeking a dynamic individual to lead conformity assessment activities for medical devices and in vitro diagnostics as the EU Medical Devices Operations Manager/Head of Notified Body. Operating under various regulations and directives, including Medical Devices Directive 93/42/EEC, Active Implantable Medical Devices Directive 90/385/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC, Medical Devices Regulation 2017/745, and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, the successful candidate will also oversee a team accredited for management system certification services, such as the Medical Device Single Audit Program (MDSAP) and ISO 13485 Certification Body.
 
 
 Key Tasks and Responsibilities

<ul>
 <li>Lead all conformity assessment activities concerning IVDR devices.
 </li>
 <li>Oversee final reviews and decision-making on certification matters.
 </li>
 <li>Establish qualification criteria and authorize personnel for conformity assessment activities.
 </li>
 <li>Manage resources, including staff, budget, operational plans, and procedures.
 </li>
 <li>Chair technical and vigilance review meetings.
 </li>
 <li>Manage a team of Quality Management Systems Auditors and Product Reviewers.
 </li>
 <li>Conduct verification of personnel performance and oversee initial and ongoing training.
 </li>
 <li>Liaise with clients, auditors, and product reviewers on various issues.
 </li>
 <li>Contribute to the corrective and preventive action team.
 </li>
 <li>Assist in HR recruitment processes for the Medical Devices Division.
 </li>
 <li>Contribute to customer relationship management implementation.
 </li>
 <li>Collaborate with international partners to expand services.
 </li>
</ul>
 
Qualifications and Experience
 
<ul>
 <li>University degree or equivalent in relevant fields (e.g., medicine, pharmacy, engineering).
 </li>
 <li>Experience in conformity assessments on medical devices, especially under IVDR or related laws.
 </li>
 <li>Four years of professional experience in healthcare products or related activities, with two years in device design, manufacture, testing, or use.
 </li>
 <li>Minimum 2 years' experience in a Notified Body as a site auditor or product reviewer.
 </li>
 <li>Knowledge of device legislation and relevant guidance documents.
 </li>
 <li>Experience in budgeting, financial management, and forecasting.
 </li>
 <li>Proficiency in risk management and device standards.
 </li>
 <li>Familiarity with conformity assessment procedures, particularly IVDR.
 </li>
 <li>Strong understanding of device technologies and industry practices.
 </li>
 <li>Knowledge of quality management systems and related procedures.
 
 
 </li>
</ul>Desirable
 
<ul>
 <li>Extensive knowledge of conformity assessment procedures (e.g., IVDR/IVDD).
 </li>
 <li>Qualifications as a lead auditor in ISO 13485, ISO 9001, ISO 17021, MDSAP, IVDD, IVDR.
 </li>
 <li>Leadership experience in complex environments.
 </li>
 <li>Demonstrated ability to lead and develop high-performing teams.
 </li>
 <li>Proficiency in IT systems and file management.
 </li>
 <li>&nbsp;
 </li>
</ul>Core Competencies
 
<ul>
 <li>Project management, financial, communication, interpersonal, and teambuilding skills.
 </li>
 <li>Exceptional written and presentation abilities.
 </li>
 <li>Strong planning, organizational, and administrative skills.
 
 
 </li>
</ul>

 For further information on this role in please contact on Gavin on 087 4108620 or connect@hero.ie
 
 


 Check out all our open jobs on our HERO Recruitment website &#150; <a href="https://www.hero.ie/">https://www.hero.ie/</a>
 


 Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.


 Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

EU Medical Devices Operations Manager

Client Manager / Industry Engagement Officer


 Galway / Dublin ( Flexible on location )


 Overview
 
 Our client's Medical Devices department operates as a notified body, overseeing various regulatory schemes including the Medical Devices Directive 93/42/EEC, Active Implantable Medical Devices Directive 90/385/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC, Commission Regulation 722/2012 Human Blood/Plasma, and Medical Devices Regulation 2017/745. Additionally, the department is accredited to provide assessment services such as MDSAP Recognised Auditing Organization, ISO 13485 Certification Body Auditing, and ISO 9001 Certification Body Auditing.
 
 
 Key Tasks and Responsibilities

<ul>
 <li>Serve as the primary point of contact for new business inquiries globally.
 </li>
 <li>Process new business inquiries using customer relations management software.
 </li>
 <li>Conduct contract reviews according to ISO 17021, MDR 2017/745, IVDR 2017/745, MDSAP.
 </li>
 <li>Provide quotation services for new business inquiries.
 </li>
 <li>Coordinate with client service representatives and medical device operations managers to schedule audits and product reviews.
 </li>
 <li>Address existing clients' inquiries regarding audit and product review statuses.
 </li>
 <li>Act as a key client manager.
 </li>
 <li>Support existing clients in transitioning from MDD/IVDD to MDR/IVDR through contracting, quotation, and scheduling activities.
 </li>
 <li>Stay updated with developments in the Irish, UK, and USA Medtech sectors.
 </li>
</ul>
 
Qualifications and Experience
 
<ul>
 <li>University or technical college degree in relevant fields (e.g., science, engineering, healthcare-related studies).
 </li>
 <li>Four years of professional experience in healthcare products or related activities, with two years specifically in device design, manufacture, testing, or use.
 </li>
</ul>Technical Competencies
 
<ul>
 <li>Knowledge of Medical Device legislation, harmonized standards, and guidance documents.
 </li>
 <li>Familiarity with Medical Device Regulation and In Vitro Diagnostic Regulation.
 </li>
 <li>Experience in contract review and quotation.
 </li>
 <li>Strong presentation skills.
 </li>
 <li>Understanding of international regulatory requirements for medical devices, including European, UK, and MDSAP.
 </li>
 <li>Analytical abilities and proficiency in writing clear, concise summary reports.
 </li>
</ul>Core Competencies
 
<ul>
 <li>Ability to work independently and within a team.
 </li>
 <li>Excellent interpersonal skills, capable of engaging with individuals at all levels.
 </li>
 <li>Strong presentation abilities.
 
 
 
 </li>
</ul>

 For further information on this role in please contact on Gavin on 087 4108620 or connect@hero.ie
 
 


 Check out all our open jobs on our HERO Recruitment website &#150; <a href="https://www.hero.ie/">https://www.hero.ie/</a>
 


 Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.


 Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Client Manager / Industry Engagement Officer 

Mechanical Fitter
 
 
 Our Client, a leading Supplier of Process Solutions to the Pharmaceutical & Medical Device &nbsp;industry are hiring a mechanical fitter for their site in East Cork. The successful candidate will be responsible for the assembly, installation, maintenance and repair of a wide range of equipment and systems.
 
 
 Responsibilities:

<ul type="disc">
 <li>Implement the scheduled preventive maintenance program.
 </li>
 <li>Perform routine inspections on mechanical equipment to detect and diagnose issues and signs of wear.
 </li>
 <li>Replace or repair worn or faulty components.
 </li>
 <li>Install, test, and commission new mechanical systems and equipment.
 </li>
 <li>Fabricate necessary parts and components when required.
 </li>
 <li>Keep precise and current records of maintenance tasks.
 </li>
 <li>Adhere strictly to safety protocols and regulations.
 </li>
 <li>Contribute to ongoing improvement efforts and offer insights for equipment enhancements.
 </li>
</ul>

 Requirements:&nbsp;

<ul type="disc">
 <li>Desirable qualification in MAMF
 </li>
 <li>Prior experience in a comparable position
 </li>
 <li>Profound understanding of mechanical systems and equipment, encompassing hydraulic and pneumatic system.
 </li>
 <li>Previous exposure to automation is advantageous
 </li>
 <li>Exceptional troubleshooting and problem-solving aptitude
 </li>
 <li>Proficiency in reading and deciphering technical drawings and schematics
 </li>
 <li>Capability to work autonomously as well as collaboratively within a team
 </li>
 <li>Physical agility and capability to lift heavy machinery
 </li>
 <li>Strong communication and interpersonal abilities
 </li>
</ul>

 For further information on this role in please contact on Gavin Moran on 087 4108620 or connect@hero.ie


 Check out all our open jobs on our HERO Recruitment website &#150; <a href="https://www.hero.ie/">https://www.hero.ie/</a>
 


 Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.


 Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Maintenance Fitter

Senior Project Administrator&nbsp;


 &nbsp;&#147;A company is only as good as their people&#148; &#150; HERO Directors


 We believe that great people make great companies and we are looking to attract a very talented Senior Project Administrator to join our great team of people and culture in HERO.
 
 Our Company
 HERO Recruitment is a multi-award winning agency.&nbsp; Our most recent accolades include winning "Agency of the Year 2019" & &#147;Best in Technical Engineering, Science and Pharmaceuticals&#148; for the last four years with the NRF (National Recruitment Federation).
 
 Our business is about 'finding the best in people' by delivering exceptional talent to our valued clients.
 
 We are a progressive agency with a down-to-earth approach.&nbsp;
 
 We are currently looking to hire a fulltime Senior Project Administrator to support our growing business onsite in our Galway offices. The right person for us will really enjoy taking big picture thinking and strategy and making it happen through excellent project administration and implementation.


 The Position

<ul>
 <li>
 The main objective of this role is to oversee and bring closure to the projects and initiatives within the business through stakeholder management, organising project tasks, timelines, and administrative follow through to completion.
 </li>
 <li>
 This position is a valued and important role in our business. The successful person will have visibility into the inner workings of the entire organisation along with our strategic aims and objectives. They will be capable of handling many tasks, projects and complex matters, on behalf of the Directors with maximum efficiency and within timelines.
 </li>
 <li>
 The role will involve liaising with company stakeholders, suppliers, team members to ensure the follow through and completion of the company vision through project breakdown and execution. This involves seeing projects through to completion and helping the Directors have full visibility on deadlines and pressing issues.
 </li>
 <li>
 In this role, you will act as the first point of contact for multiple projects, dealing with all correspondence, timelines, tasks and responsibilities surrounding the project objective and outcome.
 </li>
 <li>
 Key to the position of Senior Project Administrator will be the ability to keep full visibility on a number of new and ongoing projects and be the project owner bringing about their closure within the deadlines assigned.&nbsp;
 </li>
 <li>
 The person in this role will answer complex questions around the business or project that may require additional research and follow-up.
 </li>
 <li>
 They will be responsible for anticipating and coordinating projects/assignments along with gathering and preparing data in preparation of upcoming projects, meetings, identifying future needs to complete projects.
 </li>
 <li>
 This person will make decisions using independent judgment under only general guidelines.
 </li>
 <li>
 They will be capable of translating thoughts into documents (letters/memos/presentations, etc.); uses existing material; ensures document is logical and complete as well as accurate in grammar and spelling; makes suggestions for improvements in existing communications.
 </li>
 <li>
 They will manage work in a confidential manner, ensuring information is shared with internal and external individuals where appropriate; provides guidance to peers as necessary regarding proprietary information.
 </li>
 <li>
 The position will require someone who is talented in the drafting of reports and presentations.
 </li>
 <li>
 Key to our Senior Project Administrator role will be the supporting, problem solving and troubleshooting of issues bringing resolution and ideally closure before reaching the Directors of the business.
 </li>
 <li>
 This role offers plenty of variety; so this position will require high levels of experience with prioritising workloads to sometimes conflicting deadlines - delivered with a professional and can do approach.
 </li>
 <li>
 Valuable to this role will be the ability to overcome daily challenges potentially facing the Directors through the astute and clever initiative of the Senior Project Administrator.
 </li>
</ul>

 The Person


 The person best suited to our Senior Project Administrator role:


 Project Management and Coordinating ability that comes naturally to the person.&nbsp; They bring an ease in handling multiple tasks and projects.&nbsp; They are naturally organised and bring structure, planned processes to work and enjoy the planning, overseeing and achievement of projects. The ability to apply frameworks and methodologies throughout the lifecycle of a project is an essential quality in this person.


 Excellent Interpersonal skills with the natural ability to interact and communicate easily with anyone in or outside the company, at any level.&nbsp; They will possess a calmness and professionalism while meeting the different expectations in a busy working environment.


 Discretion and loyalty is a fundamental &#145;must have skill&#146;. Demonstrating discretion &#150; coupled with trustworthiness and reliability - while staying focused on the task.


 Organizational skills is a key attribute for our Senior Project Administrator.&nbsp; They will be well organised and detailed oriented. They will bring order to chaos.


 Multitasking skills will be a soft skill widely used; dealing with many deadlines that demand and require immediate attention will be something they have much experience in.


 Resourcefulness will be an intangible, instinctive ability that the Senior Project Administrator will need to have. It is about being able to make the impossible possible by anticipating and taking appropriate action and using all the available resources at hand to find the best solution.


 Problem Solving skills are key for this position. This senior person will be required to take and complete problems and resolve them in structured way.&nbsp; They will implement ways to avoid reoccurrence.


 The Skills & Experience

<ul>
 <li>
 All of the above under &#147;The Person&#148; plus
 </li>
 <li>
 + 5 years&#146; experience working at a senior level of Project Management and Administration. You will need to be able to demonstrate proven experience in a fast paced working environment at a Senior level role with a track record of success in organising and maintaining excellent systems and management of projects
 </li>
 <li>
 Remarkable attention to detail and highly motivated to work on their own initiative
 </li>
 <li>
 Have excellent Microsoft Office skills in Word, Excel, Outlook and PowerPoint
 </li>
 <li>
 Excellent Problem Solving and Trouble Shooting skills
 </li>
 <li>
 An exceptional organiser who has extensive experience in bring closure to projects
 </li>
</ul>

 &nbsp;


 For further information on this role with HERO, please contact Michelle Kilcar on 0868347871/091730022 or email <a href="mailto:Michelle@hero.ie">Michelle@hero.ie</a>.
 
 Check out all our open jobs on our HERO Recruitment website &#150; <a href="https://www.hero.ie/">https://www.hero.ie/</a>&nbsp;


 Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.


 &nbsp;

Senior Project Administrator

PROJECT PROCESS ENGINEER
 
 
Reporting to: Assoc Director of Automation

 The Project Engineer is responsible for safely coordinating and leading projects associated with Automation, Aseptic processing, new processing equipment, packaging, new Facility builds or modifications/extensions. The primary responsibility of the role is to ensure that the project meets its agreed goals/targets on time and on budget. The engineer reports project progress to the Project Manager to ensure the equipment/facility design and goals/targets are achieved.


 Responsibilities

<ul>
 <li>Safely coordinate the delivery of processing equipment to the site based on planned timelines and scope. Processing equipment would include e.g. autoclaves, LAF units, moulds, extruders, packaging equipment, equipment upgrades, lyophilsers, isolators, containment booths and stopper processing equipment.
 </li>
 <li>Coordination of equipment installation and services hook up, working with equipment vendors and engineering personnel.
 </li>
 <li>Lead the Project Team or support the Project Manager in Factory Acceptance Testing program.
 </li>
 <li>Coordination of all equipment documentation requirements.
 </li>
 <li>Commissioning of equipment for validation activities.
 </li>
 <li>Preparation of equipment training and maintenance protocols.
 </li>
 <li>Report into the Project Manager on project progress and advice/support on key project outcomes
 </li>
 <li>Contribute in a team environment on specific technical problem solving forums associated with product manufacture, aseptic fill and Packaging.
 </li>
 <li>Deliver Process improvement projects.
 </li>
 <li>Work with the relevant Business Unit team leaders to implement improvement opportunities
 </li>
 <li>Lead regular Equipment/Facility Project review meetings.
 </li>
 <li>Attend the weekly Tier Meetings.
 </li>
 <li>Attend monthly Department Meetings
 </li>
 <li>Attend monthly 1:1 mtg with supervisor.
 </li>
</ul>

 Requirements

<ul>
 <li>Third level qualification in an Engineering or Science or equivalent discipline/experience
 </li>
 <li>Experience of working within either the medical device or pharmaceutical industry would be an advantage but not necessary.
 </li>
 <li>5 years+ site experience in Automation or similar.
 </li>
 <li>Project Management experience is preferable but not necessary
 </li>
 <li>Interpersonal skills required to operate in a multi-function project team set up.
 </li>
 <li>Ability to work within a team and on own initiative to articulate and deliver specific functional requirements for all aspects of the project and work with members of various disciplines and functions across the project.
 </li>
</ul>

 Essential Knowledge, Skills & Abilities:

<ul>
 <li>Experience of working on a team, including strong organizational and time management skills.
 </li>
 <li>Exposure to process/equipment projects preferred.
 </li>
 <li>Experience in a GxP regulated environment is preferred.
 </li>
 <li>Experience with manufacturing systems is preferred.
 </li>
 <li>Proficient in Windows Operating System, Microsoft Office and a good understand of PLC and Scada systems preferred.
 </li>
 <li>Flexibility to respond to production issues outside normal business hours.
 </li>
 <li>Ability to learn new and different technologies.
 </li>
</ul>

 Behaviors/Value:

<ul>
 <li>Relationship Building: Establishing good working relationships with key contact members within the organization.
 </li>
 <li>Communication: Good communication and presentations skills, both written and oral &#150; ability to present production data in a clear and concise manner to team members and where required, to management.
 </li>
 <li>Planning & Organising: able to plan activities and tasks whilst ensuring the required number of people are available and in place to perform the task.
 </li>
 <li>Decision Making: identify and understand issues, problems and opportunities whilst working within a team environment to provide a solution.
 </li>
 <li>Adaptability; Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
 </li>
 <li>Passion for results: - Drive, high energy and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles.
 </li>
 <li>Receptivity to feedback - Receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate.
 </li>
 <li>Company Culture fit: Have a people centered approach in a team environment whilst upholding the values and ethos of The Company
 </li>
 <li>Other requirement (i.e. travel): Undertake any training or travel that the role may require.
 </li>
</ul>
 
For more information on this role please contact Sam Nolan on&nbsp;<a href="mailto:consult@hero.ie">consult@hero.ie</a> or 0861287244
 
 
 
Check out all our open jobs on our HERO Recruitment website &#150; https://www.hero.ie/Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

PROJECT PROCESS ENGINEER

My client is an early-stage start-up company focused on the design and development of novel medical devices.

 Position Overview We're looking for a Senior Operations Engineer with extensive skills and experience to become part of our vibrant team. The ideal candidate will have a pivotal role in supervising and enhancing our manufacturing procedures for medical devices. They'll work closely with various teams to guarantee the smooth production of top-notch products that comply with regulations and surpass customer satisfaction.


 Key Responsibilities

<ul>
 <li>Lead the design, implementation, and optimization of manufacturing processes for the pivotal device, including but not limited to product assembly, testing, and packaging.
 </li>
 <li>Provide technical support to the manufacturing line.
 </li>
 <li>Proactive monitoring of line efficiency, performance and output
 </li>
 <li>Ensure manufacturing activities are managed in accordance with the company&#146;s quality system and policies, including diligent recording of results and writing reports.
 </li>
 <li>Identify and implement opportunities for improved efficiency.
 </li>
 <li>Establish new manufacturing processes and fixtures to facilitate the introduction of new product lines.
 </li>
 <li>Define and complete process validation activities as required in accordance with the Quality System.
 </li>
 <li>Participate in risk assessments and mitigation activities related to manufacturing processes.
 </li>
 <li>Drive continuous improvement initiatives to optimize production yield, cycle time and resource utilization.
 </li>
 <li>Collaborate with R&amp;D, Quality Assurance and Regulatory Affairs team to ensure compliance with regulatory requirements and industry standards.
 </li>
 <li>Develop and maintain detailed process documentation, including manufacturing and inspection procedures , work instructions, and manufacturing batch records.
 </li>
 <li>Maintain traceability of all finished good products
 </li>
 <li>Manage equipment specification, procurement, calibration, and maintenance.
 </li>
 <li>Represent the company externally, for example at physician line tours.
 </li>
 <li>Liaise with component and service suppliers on delivery schedule and any quality problems.
 </li>
</ul>

 Requirements

<ul>
 <li>Bachelor's degree in engineering or a related technical field.
 </li>
 <li>Minimum of 5 years of experience in Operations engineering within the medical device industry.
 </li>
 <li>Strong understanding of basic engineering principles.
 </li>
 <li>Strong understanding of design control principles and regulations, including FDA QSR (21 CFR 820) and ISO 13485
 </li>
</ul>
 

 For more information on this role in please contact Johanne Kennedy on +353 86 440 3725 / choices@hero.ie


 Check out all our open jobs on our HERO Recruitment website &#150; https://www.hero.ie/


 Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval


 Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Senior Operations Engineer

Impact Through Innovation

<ul>
 <li>Lead process development on development projects, working as part of the project team.
 </li>
 <li>Development and installation of new manufacturing and process technologies to support product development and product transfers.
 </li>
 <li>Apply new technologies and methodologies to optimize process design & performance.
 </li>
 <li>Establish processes based on product specifications in line with Unit Cost metrics.
 </li>
 <li>Evaluate process and design alternatives based on Design for Manufacturability principles.
 </li>
 <li>Understand principles of lean manufacturing, problem solving, DOE.
 </li>
 <li>Complete process validation for new processes and products including IQ, OQ, PQ & PPQ.
 </li>
 <li>Working with external vendors to specify, develop and commission new process technologies.
 </li>
 <li>Setting up of new manufacturing equipment/production lines including the selection and training of process technicians and product builders, as required.
 </li>
 <li>Responsibility for and understanding of work environment issues including H&amp;S activities associated with new process development.
 </li>
 <li>Development of manufacturing processes from prototyping to full-scale production.
 </li>
 <li>The manufacture and testing of prototypes.
 </li>
 <li>Design/Source Equipment and Tooling required to meet both the capability & capacity requirements.
 </li>
 <li>Generate work plans & schedules for development activity and execute to plan.
 </li>
 <li>Lead process validation and equipment qualification activities.
 </li>
 <li>Support and mentor junior engineers.
 </li>
 <li>Adhere to all requirements of the Quality Management System.
 </li>
</ul>

 &nbsp;Required Skills

<ul>
 <li>Degree or equivalent in an engineering discipline, with 5yrs+ experience with manufacturing process design and optimization within a highly regulated environment
 </li>
 <li>Proven ability to conceptualize and deliver automated solutions as needed
 </li>
 <li>Experienced in using Six Sigma methodology for process improvement (e.g. DMAIC) and problem solving (e.g. 6-step approach)
 </li>
 <li>Experienced in statistical analysis and use of Minitab
 </li>
 <li>Experience with manufacturing process design and optimization
 </li>
 <li>Strong mechanical background with a good working knowledge of metals & plastics processing a distinct advantage
 </li>
 <li>It is essential that the candidate will be highly innovative, motivated, and organized and have excellent planning and communication skills
 </li>
 <li>Excellent SolidWorks skills.
 </li>
 <li>Experience with all or some of the following processes is a distinct advantage laser welding, reflow technologies, crimping technologies, braiding, coiling, laser cutting, injection molding, and adhesive bonding.
 </li>
</ul>

Process Development Engineer

Lead Maintenance Technician :


 The Maintenance Technician is responsible for providing high-quality facilities management, planned maintenance, and energy management services. This includes ensuring a safe, comfortable, and productive environment for business operations. The technician will perform mechanical, electrical, and general building fabric maintenance tasks, conduct preventative maintenance, troubleshoot and repair equipment, coordinate with service engineers, assist subcontractors, maintain records, and support cost reduction initiatives. They must adhere to health and safety regulations, promote continuous improvement, and contribute to safety, quality, compliance, and reporting targets.


 Requirements:

<ul>
 <li>
 Supporting production equipment within a medical device healthcare environment.
 </li>
 <li>
 Diagnosing and resolving failures in automated electro/mechanical equipment.
 </li>
 <li>
 Planning and executing preventative maintenance tasks using PEMAC.
 </li>
 <li>
 Maintaining accurate and up-to-date maintenance records.
 </li>
 <li>
 Proactively ensuring production meets performance targets.
 </li>
 <li>
 Adhering to Good Manufacturing Practices & Good Documentation Practices.
 </li>
 <li>
 Assisting with Engineering projects and leading maintenance group tasks.
 </li>
 <li>
 Prioritizing Continuous Improvement initiatives to enhance Overall Equipment Effectiveness (OEE).
 </li>
</ul>

 Preferred qualifications and experience:

<ul>
 <li>
 Certificate/Diploma/Senior Trades in Electrical/Mechanical Engineering.
 </li>
 <li>
 Minimum of 3 years of experience in a similar technical role within the medical device or related industry.
 </li>
 <li>
 Mechanical expertise within an automated manufacturing environment.
 </li>
 <li>
 Strong troubleshooting/problem-solving skills and analytical mindset.
 </li>
 <li>
 Flexibility to work varying shift patterns based on business demands.
 </li>
</ul>Additional qualifications that could further enhance your success in this role include:
 
<ul>
 <li>
 Proficiency in PLCs, motor drives, pneumatic, and hydraulic components.
 </li>
 <li>
 Demonstrated high-level technical proficiency.
 </li>
 <li>
 Excellent verbal and written communication skills.
 </li>
 <li>
 Strong teamwork abilities, fostering a collaborative work environment.
 </li>
</ul>

 For further information on this role in please contact on Gavin Moran on 087 4108620 or connect@hero.ie


 Check out all our open jobs on our HERO Recruitment website &#150; <a href="https://www.hero.ie/">https://www.hero.ie/</a>
 


 Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.


 Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Lead Maintenance Technician 

Senior Quality Engineer


 We have an exciting opportunity for a Senior Quality Engineer to join our Client, a global leader in Aerosol drug delivery devices in Galway. This is a permanent position reporting to the QA Manager and has opened due to an increased demand of our Client&#146;s products globally. This organisation is renowned for their exceptional culture, career progression and development opportunities.


 Key Responsibilities&nbsp;:

<ul>
 <li>
 Demonstrate strong leadership and a clear identifiable work ethos within the Quality Engineering Team.
 </li>
 <li>
 Lead Quality Engineering and support manufacturing process, driving process & continuous improvements.
 </li>
 <li>
 Process/manufacturing data analysis, trending, and assisting yield reporting.&nbsp;
 </li>
 <li>
 Investigation root cause analysis of quality issues in manufacturing and managing quality related NC&#146;s and CAPA&#146;s.
 </li>
 <li>
 Establish analysis techniques and other quality control tools such as SPC, Cpk, Ppk.
 </li>
 <li>
 Lead the Materials Review Board (MRB) process.
 </li>
 <li>
 Address ongoing compliance
 </li>
 <li>
 Establish inspection plans, frequencies and test methods for incoming material/parts.
 </li>
 <li>
 Appropriately train, develop and manage resources within the Quality Engineering support team to ensure objectives are communicated and delivered within agreed requirements.
 </li>
 <li>
 Ensure effective and timely closure of Quality system documentation (Audit Actions, NC&#146;s, CAPA&#146;s, Reject Report&#146;s etc)
 </li>
 <li>
 Supporting Quality Management in the development of key objectives and strategies to ensure continuous growth of personnel and quality systems improvements.
 </li>
 <li>
 Overall responsibility for GMP standards and compliance within the manufacturing area
 </li>
 <li>
 Drive risk management activities in manufacturing (Process FMECA).
 </li>
 <li>
 Manage process quality control system to ensure all manufactured product meets defined specifications prior to shipment.
 </li>
 <li>
 Maintain compliance with ISO and FDA Quality System regulations.
 </li>
 <li>
 Perform other assigned tasks and support all aspects of the Quality System as directed by the Manager.
 </li>
</ul>

 Education/Experience:

<ul>
 <li>
 Level 8 Bachelors degree in STEM
 </li>
 <li>
 5 + years of experience in a Quality Engineering capacity.
 </li>
 <li>
 Good communication skills. Must have the ability to communicate effectively at all levels of the company.&nbsp;Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner
 </li>
</ul>Thorough understanding of ISO 13485 and FDA QSR

Senior Quality Operations Engineer

<div class="tasks-container">
 <h3 class="subtitle">
 Manufacturing Engineer
 </h3>
 
 We are looking to speak with experienced Manufacturing Engineers about this great new job opportunity in Galway with one of our leading clients? This company stands out for their culture, exceptional career development pathways and unrivalled rewards and recognition packages.
 
 
 This exciting new job opportunity in Manufacturing Engineering is located in Galway, which was voted &#147;Europe's most Friendliest City 2020&#148;!
 
 
 Apply to us to find out more about this great job opportunity in Galway and we can talk through if it&#146;s the right job for you.&nbsp;
 
 <h3 class="subtitle">
 
 Responsibilities
 </h3>
 <div class="inner">
 <div class="tasks">
 <ul>
 <li>
 Taking a solution-oriented approach, diagnosing and executing permanent resolutions to manufacturing challenges using a structured problem-solving method. Advocating problem-solving practices through thorough documentation and knowledge dissemination.Propel Continuous Improvement initiatives by spearheading the integration of Lean/Six Sigma manufacturing principles.
 </li>
 <li>
 Operate within a rigorously regulated setting, ensuring the attainment of top-tier product quality by adhering to robust quality system protocols such as GMP, NCR, and CAPA, among others.
 </li>
 <li>
 Enhance production flow to achieve quality at the source, enabling prompt feedback from inspections. Ensuring adherence to product specification requirements and inspection standards through clear standard operating procedures.
 </li>
 <li>
 Lead teams in the implementation of validation procedures.
 </li>
 <li>
 Analyze and introduce innovative enhancements in operational efficiency through vital Overall Equipment Effectiveness (OEE) metrics including Yield, Uptime, and Performance. Elevate the capability, capacity, and stability of processes, products, equipment, and materials.
 </li>
 <li>
 Design mechanical jigs and fixtures to align with manufacturing needs, streamline machine changeover time, and enhance maintenance practices.
 </li>
 <li>
 Evaluate, in collaboration with EHS, the environmental impact of new equipment/processes/chemicals.
 </li>
 <li>
 Adhere to Plant Safety and Health & Safety regulations pertinent to your role, assuming accountability for those aspects of the OH&amp;S System under your purview to ensure the well-being of yourself and others.
 </li>
 <li>
 Be cognizant of the potential environmental implications associated with your work and the consequences of non-compliance.
 </li>
 <li>
 Contribute to improved energy efficiency by conserving energy wherever feasible (e.g., lighting, equipment, air conditioning, etc.).
 </li>
 <li>
 Participate in and contribute to the ongoing improvement endeavors of the OH&amp;S, Environmental, and Energy Management systems by actively engaging, providing feedback/suggestions for enhancement, and promptly reporting accidents, near misses, illnesses, good catches, and environmental incidents.
 </li>
 </ul>
 </div>
 </div>
</div>
<div class="profile-container">
 <h3 class="subtitle">
 Qualifications
 </h3>
 <div class="inner">
 <div class="profile">
 <ul>
 <li>
 Hold a NFQ Level 8 qualification in a Technical Discipline (Mechanical, Manufacturing, Mechatronics, or Biomedical) with a minimum of four years of relevant industry experience.
 </li>
 <li>
 Comprehensive knowledge and experience in validation techniques and applications (e.g., IQ/OQ/PQ, TMVs), along with associated regulatory requirements and statistical data analysis.
 </li>
 <li>
 Demonstrate a dynamic and adaptable work approach with a results-oriented mindset. Possess excellent interpersonal, communication, planning, and organizational aptitudes.
 </li>
 <li>
 Proficiency in managing mid/high-level complex technical projects within strict timelines using appropriate Project Management methodologies and tools (e.g., PMBOK).
 </li>
 <li>
 A persuasive and motivated team player who fosters and leads cross-functional collaboration. Provide technical guidance and mentorship to technicians.
 </li>
 <li>
 Possession of Project Management and Six Sigma qualifications will be advantageous.
 </li>
 <li>
 Experience in Problem Solving, Process Improvement, Data Analysis, and Project Management is highly desirable.
 </li>
 </ul>
 
 For further information on this role in please contact on Gavin Moran on 087 4108620 or connect@hero.ie
 
 
 Check out all our open jobs on our HERO Recruitment website &#150; <a href="https://www.hero.ie/">https://www.hero.ie/</a>
 
 
 
 Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
 
 
 Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
 
 </div>
 </div>
</div>

Manufacturing Engineer 

I'm your go-to engineering recruitment consultant, specialising in the incredible world of the Medical Device Industry. If you're seeking exciting Research and Development opportunities, look no further&mdash;I've got your back! When it comes to work, I'm all about giving it my all. I'm dedicated to the candidates I work with, and their victories are just as important to me as my own.
So, whether you're itching to explore fresh opportunities in the Medical Device field or simply need some expert advice, reach out without hesitation. I'm here to guide you, support you, and ensure you find the perfect fit.
Remember, I'm more than just a consultant&mdash;I'm your reliable partner on your career journey. Let's connect!
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