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53 Jobs Found 

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Extrusion Technician

Nordson

Galway
28 days ago
Galway
28 days ago

Collaboration drives Nordson’s success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.

Nordson MEDICAL designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart.Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Nordson MEDICAL workswithdoctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond. 

Purpose of position:

As an Extrusion Technician you will be involved with identifying, developing and introducing new extrusion technology. Liaising with sales, customers and suppliers and internal product design engineers to specify customer requirements with regards to dimensions, performance criteria and materials. Liaising with production to ensure extrusion equipment and processes are in place and capable. You also will be involved with the introduction of new equipment/technologies or new processes into the extrusion area or other assigned projects.

Principal Duties and responsibilities:

Manage, develop and validate new extrusion process including running extrusion trials for new product /product iterations and new technology to demonstrate capability and meet KPI’s.

Identify, specify, introduce, manage and validate new equipment and technologies in the extrusion area. Provide technical input and leadership on problem solving, resolve technical processing issues and implement process improvements in the extrusion dept.

Provide product line support for the engineering & production extrusion dept. creates documentation for extrusion equipment and process. Plan, write and execute validations for extrusion component process and technology. Control new product/process/technology introductions or changes and maintain records in accordance with the Nordson Medical quality systems to the requirements of ISO 13485 and FDC 21 CFR

Continually attain technical expertise in extrusion technologies and new materials and communicate and train extrusion personnel. Support the development of new business by working with internal design engineers, sales and customers on product and process development including costing review, feasibility studies, project timelines and technical capability assessments.

Drive the Nordson medical centre of extrusion excellence by relentlessly focusing on continuous improvement in processes, capability, equipment and business processes as well as identification of advancements in materials or equipment appropriate to be introduced to Nordson Medical.

Introduce improvement initiatives as assigned including investigations, trouble shooting, driving effective determination of root cause and championing a structured approach to problem solving using lean tools and 6 sigma principals.

Person Specification:

  • Primary degree or equivalent in Polymer, manufacturing or mechanical engineering;

  • 8 to 10 years Extrusion process experience;

  • 3 to 5 years Medical device or manufacturing experience is essential;

  • Hands on experience in extrusion and plastics material knowledge are essential;

  • Be a self-starter with good motivational and inter-personal skills;

  • A Practical level-headed individual with strong technical ability.

Travel: Less than 5% (other Nordson divisions and customers)

Collaboration drives Nordson’s success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.

Nordson MEDICAL designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart.Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Nordson MEDICAL workswithdoctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond. 

Purpose of position:

As an Extrusion Technician you will be involved with identifying, developing and introducing new extrusion technology. Liaising with sales, customers and suppliers and internal product design engineers to specify customer requirements with regards to dimensions, performance criteria and materials. Liaising with production to ensure extrusion equipment and processes are in place and capable. You also will be involved with the introduction of new equipment/technologies or new processes into the extrusion area or other assigned projects.

Principal Duties and responsibilities:

Manage, develop and validate new extrusion process including running extrusion trials for new product /product iterations and new technology to demonstrate capability and meet KPI’s.

Identify, specify, introduce, manage and validate new equipment and technologies in the extrusion area. Provide technical input and leadership on problem solving, resolve technical processing issues and implement process improvements in the extrusion dept.

Provide product line support for the engineering & production extrusion dept. creates documentation for extrusion equipment and process. Plan, write and execute validations for extrusion component process and technology. Control new product/process/technology introductions or changes and maintain records in accordance with the Nordson Medical quality systems to the requirements of ISO 13485 and FDC 21 CFR

Continually attain technical expertise in extrusion technologies and new materials and communicate and train extrusion personnel. Support the development of new business by working with internal design engineers, sales and customers on product and process development including costing review, feasibility studies, project timelines and technical capability assessments.

Drive the Nordson medical centre of extrusion excellence by relentlessly focusing on continuous improvement in processes, capability, equipment and business processes as well as identification of advancements in materials or equipment appropriate to be introduced to Nordson Medical.

Introduce improvement initiatives as assigned including investigations, trouble shooting, driving effective determination of root cause and championing a structured approach to problem solving using lean tools and 6 sigma principals.

Person Specification:

  • Primary degree or equivalent in Polymer, manufacturing or mechanical engineering;

  • 8 to 10 years Extrusion process experience;

  • 3 to 5 years Medical device or manufacturing experience is essential;

  • Hands on experience in extrusion and plastics material knowledge are essential;

  • Be a self-starter with good motivational and inter-personal skills;

  • A Practical level-headed individual with strong technical ability.

Travel: Less than 5% (other Nordson divisions and customers)

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Senior R&D Engineer

Medtronic

County Galway
8 days ago
County Galway
8 days ago
Description

MEDTRONIC


At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations


OUR PURPOSE


At our world leading Research & Development Department in Medtronic, plc, we focus on the development of cutting-edge medical devices in the Cardiac and Vascular space. Our Engineers are directly involved in the development of innovative products for use in medical procedures. As a Senior R&D Engineer, you will be tasked with supporting a team in the technical development of new products through early stage investigation/research and/or translation of that into commercial medical devices.


Come for a job, stay for a career!


A DAY IN THE LIFE:

  • Design, develop, analyze, troubleshoot and provides technical skills during research and / or product development Effectively represent Medtronic while interacting with physicians to filter their needs into product requirements and concepts
  • Participate in technical innovation across the department
  • Identify and mitigate technological risks throughout the design process
  • Apply understanding of anatomy & physiology with engineering knowledge in materials and processes to generate feasible designs
  • Interface effectively and build relationships with team members, other staff and key technology and component suppliers, both locally and globally
  • Play a key role on the product /process /engineering /leadership fronts potentially progressing a project from concept phase into commercialization phase
  • Contribute to resolution of technical challenges with existing designs and support portfolio sustaining activities
  • Contribute to generation of intellectual property
  • Delegate/direct work of experienced engineers
  • Provide coaching/guidance to less experienced team members

Qualifications

KEY SKILLS & EXPERIENCE

  • Qualified person to Bachelor/Master’s Degree level 8 in Mechanical, Biomedical or related engineering discipline and with a minimum of 5 years relevant experience.
  • Dynamic team player and can work effectively and proactively on cross-functional teams.
  • Medical device product development experience would be advantageous
  • You are an experienced professional in engineering development with extensive engineering knowledge and skills in some or all of the following: component and system design, materials (polymers and metals), sterilization of medical devices, test method development, design for six sigma principles, CAD (Solidworks preferred), pre-clinical evaluations, physician interactions, knowledge of anatomical use conditions (anatomy, physiology etc.), system requirements development, design control, application of ISO standards for medical devices
  • Collaborate across organizational boundaries and take appropriate actions when problems occur
  • You are a good communicator and fluent in English, both in writing and speaking
  • High level of enthusiasm and motivation, and the ability to take input from others are desirable
  • You are someone who loves how and why things work, and you bring this passion to work with you


Medtronic offer a competitive Salary and flexible Benefits Package

EMEA-Ireland-County Galway
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MDR/Vigilance Specialist

HRM Recruit

Galway, Galway
21 days ago
Galway, Galway
21 days ago

Our client is a global leader in the Medical Devices industry sector. They have undergone significant growth in the past year, and are seeking an experienced MDR/Vigilance Specialist to join the team at their state-of-the-art facility in Galway on a 12 month contract basis. Fully remote working options are available.
The Role
Duties and responsibilities of the MDR/Vigilance Specialist will include but are not limited to:
  • Oversight of complaint handling activities for a wide range of products
  • Overseeing secondary approval of regulatory reporting decisions
  • Timely submission of US Medical Device Report (MDR) and EU Vigilance Reports to external regulatory agencies
  • Support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports
  • Support complaint trend analysis and annual post market surveillance reports for various products
  • Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information
  • Contribute to continuous improvement activities
  • Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies
  • Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements

The Person
You will have skills and experience in the following:
  • BSc and 2+ years of relevant industry experience
  • Candidates with a clinical/medical background will also be considered (e.g. registered nurse or experience in physiological or clinical measurement science)
  • Experience/understanding of complaint handling or CAPA processes are desirable
  • Audit experience desirable
  • Must be a dynamic team player who can work effectively and proactively on cross-functional teams
  • Must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.
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Key Account Manager

FRS Recruitment

Galway, Galway
7 days ago
Galway, Galway
7 days ago

Key Account Manager: Connacht
Medical Device/Consumables
Key Account Manager, you will ensure service to our Key Accounts, tailored to meet their needs. You will add value to customers by pro-actively advising on up to date best practice, products, and cost-saving initiatives while maximizing the revenue and profitability associated with our key customers
Key Account Manager
  • Responsible for the relationship with key accounts ensuring that service levels and customer satisfaction is maintained by identifying key departmental decision-makers and influencers
  • Develop a comprehensive understanding of the Key Accounts business including current and projected demand patterns, strategic initiatives, and supplier expectations, solving issues and troubleshooting, risk.
  • Negotiation of long-term supply contracts with suppliers to ensure continuity of supply for the customer and revenue
  • Responsible for sales budgets and business plan for key accounts ensuring target is achieved on an annual basis
  • Leverage the knowledge of internal product specialists to assist with new business opportunities
  • Manage the Vendor Managed Inventory (VMI) process for Key Accounts and monitor customer stock levels
  • Ensure that all potential new business is identified, and act on these opportunities
  • Build relationships with key suppliers to ensure that we can negotiate the best possible terms for our key customers

Requirements of Key Account Manager
  • Strong Key Account Management experience with the ability to commute with stakeholders at a senior level
  • Key Account and or Sales experience within the Medical Industry
  • Experience in working with customers who have FDA regulated products an advantage
  • Sales focused with the ability to identify opportunities
  • Exceptional commercial ability, capable of negotiating and executing on significant commercial deals
  • Clean full driving license

Excellent Basic + Commission Structure
Leading the way in the Recruitment of Sales Professionals
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R&D Engineer 1( New HC)

Integer

Galway
1 day ago
Galway
1 day ago
At Integer, our vision and values are embedded in everything we do!
If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!
JOB SUMMARY:
This position provides product design & engineering support for new or existing catheter and guidewire products. In this position, the R&D engineer works as part of the development team bringing a variety of products from conceptualization to commercial ready. He/she learns to use and apply professional concepts while making effective contributions to the business.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Employees are expected to support the quality concepts inherent in the business philosophies of Integer Ireland including a variety of job related tasks, which may not be specific to this position profile.
Accountabilities include:
The main function of this role is to support or lead development of new products meeting business needs and through the adherence to internal procedure and regulatory requirements. Adheres to Integer core values and all safety, environmental, security and quality requirements including, but not limited to Medical device regulations, Safety regulation, Environmental and Security Management Systems regulation, company policies and operating procedures, and other regulatory requirements. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgement in making minor adaptations and modifications. Analyzes data and makes recommendations for change to products and processes. Recognizes discrepancies in results and follows operations through a series of related detailed steps or processes. Reviews test procedures and plans prior to implementation, conducts failure analysis and inspection on products, processes and materials. Investigates, develops and implements new process technologies of limited scope. Executes on various initiatives as required by supervisor. Prepares product documentation, engineering reports documenting results, conclusions and provides recommendations for next steps as appropriate. Prepares presentations and delivers results to project teams.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
+ Minimum of Bachelor’s degree in Engineering or Material Science.
+ 0-3 years’ experience in a similar manufacturing environment.
SKILLS AND KNOWLEDGE:
+ FUNCTIONAL KNOWLEDGE: Requires conceptual knowledge of theories, practices and procedures in mechanical or biomechanical engineering.
+ BUSINESS ACUMEN: Applies general knowledge of business developed through education or past experience.
+ LEADERSHIP: Accountable for technical contributions to the team.
+ PROBLEM SOLVING: Seeks to identify innovative approaches to solve standard problems; analyzes information and utilizes standards practices to make judgements.
+ IMPACT: Impacts own work and contributes to achievement of team goals and objectives.
+ COMMUNICATION & INTERACTION: Exchanges information, asks questions and checks for understanding.OTHER:Knowledge of engineering theories, methods and work measurement techniques.
+ Knowledge of techniques and tools for develop manufacturing products and processes is an advantage e.g. DoE, statistical techniques, sampling size, six sigma, minitab etc..
+ Proficiency and experience in 2D and 3D CAD Modelling using Solidworks or equivalent is an advantage.
PHYSICAL DEMANDS.
+ Primarily work in a sitting position.
+ Occasional must be able to carry up to 10 lbs and lift up to 24 lbs.
+ Complete Plant Mobility MENTAL DEMANDS
+ As per skills & Knowledge section. WORKING CONDITIONS:
+ Day-shift operation, but may be required to change working hours or work other shift patterns occasionally as project responsibility dictates. REPORTING RELATIONSHIP AND PRESENCE OR SUPERVISOR.
+ This position reports directly to an Engineering Lead (Senior R&D Engineer or higher).
+ Receives supervision and works directly from an Engineering project list.
Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at https://integer.net .
Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at
716-759-5739.
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Manufacturing Engineer NPI/Projects

Sigmar

Galway, Galway
17 days ago
Galway, Galway
17 days ago

Manufacturing Engineer

Come join a company who is passionate about saving lives, developing the newest technologies for the treatment of some of healthcare’s toughest problems and the lives of their employees.

My client, a leading medical device company based in Galway, are seeking enthusiastic, technical and hard-working engineers to join their Manufacturing teams.

We have positions available in NPI, Projects and Line Support.

What they can offer you:

  • A Career with a Meaningful Purpose
  • A Collaborative Culture
  • A defined Career Development plan
  • The Opportunity to Develop and Innovate
  • Competitive Benefits
  • An excellent Work-Life Balance
  • Dedicated Corporate Social Responsibility

Your Responsibilities:

  • Troubleshoots new products / process working closely with product development.
  • Continually seeks to drive / improvements in process design, layout and operational performance.
  • Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
  • Actively promotes and participates in a cross -functional teamwork environment.
  • Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
  • Gives technical guidance to Associate Engineers and technicians.
  • Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
  • Demonstrate a primary commitment to patient safety and product quality.
  • Understands and comply with all the regulations governing the quality systems.

 

Your Background/Skills:

  • A Level 8 Degree (240 Credits) or equivalent in an Engineering or Science related discipline.
  • A minimum of 2-4 years’ experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment.
  • Project Management experience desirable but not essential.

For more information, please contact Emma on 091 455 307.

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

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Senior Supplier Engineer

Sigmar

Galway City, Galway
20 days ago
Galway City, Galway
20 days ago

Senior Supplier Engineer | Galway | Permanent.

Our client, a global leader within the Medical Device industry is looking for a Senior Supplier Engineer to join their team on a permanent basis.  

You will be a part of the Materials Supplier Engineering Team where you will be concentrating on all aspects of supplier selections, processes, and material changes.

What you will be responsible for:

  • You will be the technical lead on teams which have representatives from various departments.
  • You will be responsible for Establishing & Achieving business objectives of the Team in terms of Quality, Cost and Service.
  • You will provide guidance to other functional areas in applying Supplier Management system requirements
  • You will drive continuous improvement of quality and quality systems, service capability and total cost of ownership throughout the supply chain.
  • You will support investigations of material quality.
  • You will also ensure that adequate Corrective Actions are identified, implemented, and controlled by Suppliers.
  • You will work with Procurement, Supplier Quality Engineering, Receiving Inspection & Business units to ensure that components meet established requirements.
  • You will contribute to the development, maintenance and improvement of Supplier Management Policies and Procedures.
  • You will develop new Supply sources with Procurement Team.
  • You will identify and drive Material Value Improvement Projects (VIP’s) throughout the Supply.
  • You will communicate effectively with all Internal & External Stakeholders.

What we need from you:

  • Bachelor of Science (NFQ level 8/ 240 credits) in Engineering, Life Science or Physics.
  • People management experience is mandatory. 
  • Minimum 5 years’ experience working in Supplier Management.
  • Experience in Medical Device industry is preferred.
  • 6 Sigma qualification an advantage.
  • General knowledge of industry practices, techniques, and standards
  • At ease working under general direction regarding the progress of projects and special assignments
  • Excellent communication skills
  • Working knowledge of Supplier interaction is an advantage.

What we can offer you:

  • Comprehensive Benefits.
  • Career Growth.
  • Life - Work integration.
  • The opportunity to make a difference in people’s lives.

If you are intersted in this job, please apply with a copy of your updated CV to Rebecca O'Connor at ROconnor@sigmar.ie 

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

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Quality Systems Compliance Specialist

Sigmar

Connacht, Galway
17 days ago
Connacht, Galway
17 days ago

Quality Systems Compliance Specialist

The role requires a minimum of 3 years quality management systems experience in the medical device industry and the candidate must exhibit excellent problem solving and an innovative rational mindset to ensure implementation of advanced, efficient appropriate quality management practices.

Responsibilities:

  • Support and coordinate improvement programs including conducting CAPA analysis to determine root cause and complete problem resolution
  • Coordinate the internal audit program and ensure that Internal Audits are completed
  • Support the preparation and conduct of External Audits
  • Support compliance and continuous improvement QMS related projects
  • Support interactions with certification bodies in relation to QMS auditing, certification, and changes.
  • Support processes for monitoring and measurement of processes including generation of routine QMS performance reports, objectives and KPIs

Experience:

  • Minimum 5 years’ experience in a relevant role in the medical device industry
  • Degree in Quality Assurance, Quality Engineering or similar qualifications
  • Broad experience of Medical Device Quality Management Systems,
  • Experience in CAPA system management,
  • Experience in Complaint handling systems,
  • A working knowledge of FDA requirements and managing regulatory body audits,
  • Proven ability of working in a cross-functional team environment,
  • Knowledge and practical experience with the use of statistical techniques,
  • Training and experience in auditing (internal auditing, supplier auditing or similar),
  • Detail oriented with focus on implementing efficient systems for QMS Compliance.

 

To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

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Manufacturing Engineer I / II Galway Job (Galway, G, IE)

Boston Scientific

Galway
9 days ago
Galway
9 days ago

 

For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine.  The Company's products help physicians and other medical professionals improve their patients' quality of life by providing alternatives to surgery.  Since 1994, employees in Galway have been at the forefront of some of these truly innovative medical device designs and manufacturing. 

Job Purpose

Provide scientific understanding and technical engineering skills to meet business goals and objectives. Ability to coach, lead and enhance the productivity of technical reports within the business. Provide a structured framework for training of technical reports. Build collaborative relationships through strong teamwork across the organization.

 

Key Responsibilities

  • Providing technical leadership on product and process issues.
  • Leading technical improvement under the team’s VIP program.
  • Transferring and implementing processes either from development or from another manufacturing facility.
  • 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 technical leadership/guidance for the Process Technician on the team (with specific responsibility to ensure that the preventative maintenance program is adequate and timely).
  • 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 comply with all the regulations governing the quality systems
  • Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

Qualifications

  • NFQ Level 8 qualification (240 ECTS points) in engineering or a relevant field,
  • Minimum of 2 years' relevant experience to include line support engineering.
  • Medical Device or other highly regulated background highly desired.
  • Good technical capabilities, communication skills, teamwork abilities and initiative.
  • Project Management experience desirable.
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Senior R&D Engineer

Integer

Galway
17 days ago
Galway
17 days ago
At Integer, our vision and values are embedded in everything we do!
If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!
Job Summary:
Integer is looking for a talented, enthusiastic & experienced Senior Research & Design Engineer to join a dynamic R&D team developing innovative guidewire and catheter based devices. You will have the responsibility for providing leadership and technical support to product development programs across a wide spectrum of applications including peripheral, neurovascular, coronary therapy areas.
Essential job duties and responsibilities:
The main function of this role is to act as the technical lead for product development projects through the design life cycle from concept to commercialization as defined by Lake Region procedures
Responsibilities include:
+ Manage & lead product development activities with respect to:Product Design & Development.Product and Project Costing.Meeting agreed timelines.Risk mitigationSupporting the preparation of regulatory submissions as required
+ Translate customer needs into design inputs and requirements
+ Provide critical input to product characterization & development activities, to include test method development and validation.
+ Develop and support design related documentation including Design History File generation
+ Identify and mitigate technological risks throughout the design process.
+ Project management using standard methodology.
+ Build relationships with team members, other staff and key technology and component suppliers across the site and organisation
+ Transfer of new products & processes to production, both within and between sites.
+ Provide coaching/guidance to less experienced team members.
+ Effectively represent the company when interacting with customers MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS: Minimum of Bachelor’s degree in Engineering, Material Science or equivalentMinimum of 5 years of relevant industrial experience preferably in the medical device industries or other comparable industries (e.g. electronics, automotive etc..). SKILLS AND KNOWLEDGE: Knowledge of engineering theories, methods and work measurement techniques
+ Ability to communicate and work with people inside and outside the Department as necessary to execute these responsibilitiesAbility to coach & mentor assigned employees
+ Ability to understand and follow appropriate departmental policies, procedures, practices and to understand inter-relationships of people and functions
+ Knowledge of design principles, FMEA, sterilization, project management, regulatory requirements and standards, test development.
+ Experience in guidewire and catheter development an advantage MENTAL DEMANDS.
+ Innovative
+ Result driven
+ Self-starter
+ Organised
+ Attention to detail.
+ Good team worker
+ Good analytical and problem solving
Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at https://integer.net .
Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at
716-759-5739.

Posted

28 days ago

Description

Collaboration drives Nordson’s success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.

Nordson MEDICAL designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart.Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Nordson MEDICAL workswithdoctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond. 

Purpose of position:

As an Extrusion Technician you will be involved with identifying, developing and introducing new extrusion technology. Liaising with sales, customers and suppliers and internal product design engineers to specify customer requirements with regards to dimensions, performance criteria and materials. Liaising with production to ensure extrusion equipment and processes are in place and capable. You also will be involved with the introduction of new equipment/technologies or new processes into the extrusion area or other assigned projects.

Principal Duties and responsibilities:

Manage, develop and validate new extrusion process including running extrusion trials for new product /product iterations and new technology to demonstrate capability and meet KPI’s.

Identify, specify, introduce, manage and validate new equipment and technologies in the extrusion area. Provide technical input and leadership on problem solving, resolve technical processing issues and implement process improvements in the extrusion dept.

Provide product line support for the engineering & production extrusion dept. creates documentation for extrusion equipment and process. Plan, write and execute validations for extrusion component process and technology. Control new product/process/technology introductions or changes and maintain records in accordance with the Nordson Medical quality systems to the requirements of ISO 13485 and FDC 21 CFR

Continually attain technical expertise in extrusion technologies and new materials and communicate and train extrusion personnel. Support the development of new business by working with internal design engineers, sales and customers on product and process development including costing review, feasibility studies, project timelines and technical capability assessments.

Drive the Nordson medical centre of extrusion excellence by relentlessly focusing on continuous improvement in processes, capability, equipment and business processes as well as identification of advancements in materials or equipment appropriate to be introduced to Nordson Medical.

Introduce improvement initiatives as assigned including investigations, trouble shooting, driving effective determination of root cause and championing a structured approach to problem solving using lean tools and 6 sigma principals.

Person Specification:

  • Primary degree or equivalent in Polymer, manufacturing or mechanical engineering;

  • 8 to 10 years Extrusion process experience;

  • 3 to 5 years Medical device or manufacturing experience is essential;

  • Hands on experience in extrusion and plastics material knowledge are essential;

  • Be a self-starter with good motivational and inter-personal skills;

  • A Practical level-headed individual with strong technical ability.

Travel: Less than 5% (other Nordson divisions and customers)

Collaboration drives Nordson’s success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.

Nordson MEDICAL designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart.Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Nordson MEDICAL workswithdoctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond. 

Purpose of position:

As an Extrusion Technician you will be involved with identifying, developing and introducing new extrusion technology. Liaising with sales, customers and suppliers and internal product design engineers to specify customer requirements with regards to dimensions, performance criteria and materials. Liaising with production to ensure extrusion equipment and processes are in place and capable. You also will be involved with the introduction of new equipment/technologies or new processes into the extrusion area or other assigned projects.

Principal Duties and responsibilities:

Manage, develop and validate new extrusion process including running extrusion trials for new product /product iterations and new technology to demonstrate capability and meet KPI’s.

Identify, specify, introduce, manage and validate new equipment and technologies in the extrusion area. Provide technical input and leadership on problem solving, resolve technical processing issues and implement process improvements in the extrusion dept.

Provide product line support for the engineering & production extrusion dept. creates documentation for extrusion equipment and process. Plan, write and execute validations for extrusion component process and technology. Control new product/process/technology introductions or changes and maintain records in accordance with the Nordson Medical quality systems to the requirements of ISO 13485 and FDC 21 CFR

Continually attain technical expertise in extrusion technologies and new materials and communicate and train extrusion personnel. Support the development of new business by working with internal design engineers, sales and customers on product and process development including costing review, feasibility studies, project timelines and technical capability assessments.

Drive the Nordson medical centre of extrusion excellence by relentlessly focusing on continuous improvement in processes, capability, equipment and business processes as well as identification of advancements in materials or equipment appropriate to be introduced to Nordson Medical.

Introduce improvement initiatives as assigned including investigations, trouble shooting, driving effective determination of root cause and championing a structured approach to problem solving using lean tools and 6 sigma principals.

Person Specification:

  • Primary degree or equivalent in Polymer, manufacturing or mechanical engineering;

  • 8 to 10 years Extrusion process experience;

  • 3 to 5 years Medical device or manufacturing experience is essential;

  • Hands on experience in extrusion and plastics material knowledge are essential;

  • Be a self-starter with good motivational and inter-personal skills;

  • A Practical level-headed individual with strong technical ability.

Travel: Less than 5% (other Nordson divisions and customers)

Source: Nordson