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11Jobs Found

11 Jobs Found

Supplier Process Engineer

Headcount Solutions

Limerick, Limerick

19 days ago

Limerick, Limerick

19 days ago

Headcount Solutions is seeking a Supplier Engineer for a client’s Medical Device manufacturing facility. This person will manage suppliers and supplier changes, from an engineering perspective, and to lead opportunities for the reduction of cost, yield or quality improvements with existing or new vendors.

Main Responsibilities:

Liaise with Sustaining Engineering, and other departments, to develop and introduce new products, components and processes in key supplier sites.
In conjunction with Sustaining Engineering and Supplier Quality engineering, support and advise suppliers on validation requirements as necessary.
Work with internal groups to review and assess the impact of supplier change requests, and responsibility for implementation and approval of same.
Support the assessment of non-conforming raw materials received from suppliers.
Liaise with Purchasing and Supplier Quality Engineering to improve the Quality Systems procedures relating to suppliers.
Identify and capitalise on opportunities for the reduction of cost, yield or quality improvements with existing or new vendors, via process improvement or transfer.
Assess current internal supplier processes to streamline and optimise.
Liaise with the Purchasing group to identify new suppliers as needed.
Liaise with Supplier Quality Engineering and Sustaining Engineering (CAPA) to ensure the effective completion of Supplier Corrective Actions (SCA’s)
Collaborate with Purchasing and Legal to ensure the development and implementation of effective supply agreements with suppliers.
Ensure effective reporting to the Engineering Management team.
Provide technical support and input when required to the Suppler Audit process.
Responsible for operating general internal quality systems and documentation.

Requirements:

Formal Production/Engineering qualification and relevant experience in as least one of the following areas: Manufacturing, Engineering/Device Design & Development/CAPA.
Strong interpersonal skills and the ability to communicate at all levels of the organisation.
Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
Proven Project Management and problem-solving skills.

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie

Supplier Process Engineer

Headcount Solutions

Limerick, Limerick

19 days ago

Limerick, Limerick

19 days ago

Main Responsibilities:

Liaise with Sustaining Engineering, and other departments, to develop and introduce new products, components and processes in key supplier sites.
In conjunction with Sustaining Engineering and Supplier Quality engineering, support and advise suppliers on validation requirements as necessary.
Work with internal groups to review and assess the impact of supplier change requests, and responsibility for implementation and approval of same.
Support the assessment of non-conforming raw materials received from suppliers.
Liaise with Purchasing and Supplier Quality Engineering to improve the Quality Systems procedures relating to suppliers.
Identify and capitalise on opportunities for the reduction of cost, yield or quality improvements with existing or new vendors, via process improvement or transfer.
Assess current internal supplier processes to streamline and optimise.
Liaise with the Purchasing group to identify new suppliers as needed.
Liaise with Supplier Quality Engineering and Sustaining Engineering (CAPA) to ensure the effective completion of Supplier Corrective Actions (SCA’s)
Collaborate with Purchasing and Legal to ensure the development and implementation of effective supply agreements with suppliers.
Ensure effective reporting to the Engineering Management team.
Provide technical support and input when required to the Suppler Audit process.
Responsible for operating general internal quality systems and documentation.

Requirements:

Formal Production/Engineering qualification and relevant experience in as least one of the following areas: Manufacturing, Engineering/Device Design & Development/CAPA.
Strong interpersonal skills and the ability to communicate at all levels of the organisation.
Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
Proven Project Management and problem-solving skills.

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie

Senior Industrial Engineer

Sigmar

Tipperary, Tipperary

5 days ago

Tipperary, Tipperary

5 days ago

This well established medical devices brand with a reputation for validation is hiring a Senior Industrial Engineer for their team.

Responsible for driving operational excellence through the manufacturing and business environments through the designing, and implementing of systems to meet all key performance indicators. This requires working and influencing cross-functionally and globally.

Job Responsibilities:

Leading and championing major CI initiatives across the site.
Nurturing commitment to the vision, mission, objectives, and values of the company.
Shaping, developing, and aligning the strategies of the Operational Excellence team
Coaching functional and production leaders on the principles of lean & Operational Excellence.
Leading site Kaizen events to achieve financial or strategic objectives
Holding detailed knowledge and can teach others on all Lean tools
Proven track record in Project Management and delivery of results
Driving changes with the Product design and engineering teams.
Driving the operational Excellence strategy on-site, developing and driving new strategy, systems and tools.

Job Requirements:

Bachelors Degree or Masters in Lean / Operational Excellence (Level 8 minimum)
Previous experience in a similar role within a highly regulated environment
6 Sigma green or black belt

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

Supplier Process Engineer

Cook Group

Limerick

22 days ago

Limerick

22 days ago

The primary function of this position is to manage Cook Ireland’s process engineering requirements with respect to suppliers and supplier changes, and to lead opportunities for the reduction of cost, yield or quality improvements with existing or new suppliers.

Reporting to: Senior Sustaining Engineer

Find out more about Cook Medical here

Liaise with Sustaining Engineering, and other departments, to develop and introduce new products, components and processes in key supplier sites.
Lead process engineering projects to implement supplier based changes, from feasibility through to, validation, qualification and implementation.
In conjunction with Sustaining Engineering and Supplier Quality engineering, support and advise suppliers on validation requirements as necessary.
Work with internal groups to review and assess the impact of supplier change requests, and responsibility for implementation and approval of same. Become a Subject Matter Expert (SME) of Cook Ireland’s supplier processes.
Establish and develop good working relationships with Cook Ireland suppliers.
Support the assessment of non-conforming raw materials received from suppliers.
Liaise with Purchasing and Supplier Quality Engineering to improve the Quality Systems procedures relating to suppliers.
Identify and capitalise on opportunities for the reduction of cost, yield or quality improvements with existing or new vendors, via process improvement or transfer.
Assess current internal supplier processes to streamline and optimise.
Liaise with the Purchasing group to identify new suppliers as needed.
Liaise with Supplier Quality Engineering and Sustaining Engineering (CAPA) to ensure the effective completion of Supplier Corrective Actions (SCA’s)
Ensure effective reporting to the Engineering Management team.
Provide technical support and input when required to the Suppler Audit process.
Liaise with supplier and regulatory to obtain the supplier related information required for regulatory submissions.

Ensure the Supplier Engineering team compliant with:
- Cook’s Code of Conduct.
- Cook’s Quality System requirements.
- Company HR policies.

Liaise with other Cook manufacturing facilities.
Benchmark systems and processes against best industry practice and modify and develop accordingly to further improve operations efficiencies.
Responsible for operating general internal quality systems and documentation.

Supplier Process Engineer

Cook Group

Limerick

23 days ago

Limerick

23 days ago

Overview

Reporting to: Senior Sustaining Engineer

Find out more about Cook Medical here

Responsibilities

Liaise with Sustaining Engineering, and other departments, to develop and introduce new products, components and processes in key supplier sites.
Lead process engineering projects to implement supplier based changes, from feasibility through to, validation, qualification and implementation.
In conjunction with Sustaining Engineering and Supplier Quality engineering, support and advise suppliers on validation requirements as necessary.
Work with internal groups to review and assess the impact of supplier change requests, and responsibility for implementation and approval of same. Become a Subject Matter Expert (SME) of Cook Ireland’s supplier processes.
Establish and develop good working relationships with Cook Ireland suppliers.
Support the assessment of non-conforming raw materials received from suppliers.
Liaise with Purchasing and Supplier Quality Engineering to improve the Quality Systems procedures relating to suppliers.
Identify and capitalise on opportunities for the reduction of cost, yield or quality improvements with existing or new vendors, via process improvement or transfer.
Assess current internal supplier processes to streamline and optimise.
Liaise with the Purchasing group to identify new suppliers as needed.
Liaise with Supplier Quality Engineering and Sustaining Engineering (CAPA) to ensure the effective completion of Supplier Corrective Actions (SCA’s)
Ensure effective reporting to the Engineering Management team.
Provide technical support and input when required to the Suppler Audit process.
Liaise with supplier and regulatory to obtain the supplier related information required for regulatory submissions.

Qualifications

Ensure the Supplier Engineering team compliant with:
- Cook’s Code of Conduct.
- Cook’s Quality System requirements.
- Company HR policies.

Liaise with other Cook manufacturing facilities.
Benchmark systems and processes against best industry practice and modify and develop accordingly to further improve operations efficiencies.
Responsible for operating general internal quality systems and documentation.

Manufacturing Engineer

Microchip

Ennis

30+ days ago

Ennis

30+ days ago

Company Description

Microchip Technology Inc. is a leading provider of embedded control applications. Our product portfolio comprises general purpose and specialized 8-bit, 16-bit, and 32-bit microcontrollers, 32-bit microprocessors, field-programmable gate array (FPGA) products, a broad spectrum of high-performance linear, mixed-signal, power management, thermal management, radio frequency (RF), timing, safety, security, wired connectivity and wireless connectivity devices, as well as serial Electrically Erasable Programmable Read Only Memory (EEPROM), Serial Flash memories, Parallel Flash memories, and serial Static Random Access Memory (SRAM). We also license Flash-IP solutions that are incorporated in a broad range of products.

Job Description

As a Manufacturing Engineer you will be a key member of the engineering team at Microchip, responsible for ensuring that our products meet customer needs and have the highest quality. Through part requirement analysis, definition, and selection, ensure product is correctly processed through screening and sampling operations as required by governing bodies and internal requirements. Create and maintain Process and Product definition with associated process controls and automation.

Role Focus

Combining mechanical, electrical, and software principles and their application; identify, develop, and drive continuous improvement programs towards further automation within the facility.
Guide and drive on-site equipment appraisal initiatives for process standardization, quality improvement, and H&S developments where identified.
Understand HTRB and Burn-in screening principles, our products and processes to ensure compliance and maximum yield.
Understand DC and AC test principles, our products, related equipment and processes to ensure compliance and maximum yield.
Ensure compliance with DLA test methods.

Key job responsibilities/duties include:

Review and disposition production lots based on electrical test screening.
Perform in-depth and controlled studies of specific/chronic problems and processes as required and specify corrective/preventative action as appropriate.
Responsible for analysis and performance improvement of key metrics for assigned processes and/or products.
Understanding of reliability theory and principles and application to Microchip products and processes.
Consult with international Microchip Divisions and test equipment suppliers to ensure best practices in the use of test and screening equipment.
Understand and implement Microchip Irelands’ Quality Manual and related in-house procedures as they apply to assigned processes and new products.
Understand Government Specifications as they apply to assigned product and processes.
Implement Lean and support continuous improvement programmes.
Support in-house training programmes as required.
Ensure effective and professional communication with Microchip divisions, customers and vendors.
Take on other engineering duties as required and assigned.
Create and update internal product and process documents, in accordance with product requirements
Support Tactical Marketing, Planning and Engineering departments for new and existing product queries. Determine alternative product selection where required.
Understand and implement Microchip Quality Policies and related in-house procedures as they apply to assigned processes and new products.

Job Requirements

Qualifications and Experience

Level 8 Degree in Engineering (preferably Electronic Engineering) or Level 8 Degree in Physics.
Experience preferably in a component manufacturing, medical device or other highly regulated environment.
User knowledge of LabVIEW and Minitab, JMP, Python, SolidWorks, CAD and AUTOCAD software packages.
Knowledge of DLA and/or ISO standards is an advantage.
Qualifications in, or previous exposure to Lean, Six Sigma, 5S, DOE, DMAICs or FMEAs is an advantage.
Experience in equipment appraisal towards CE compliance is an advantage.

Competencies

Strong electronic and mechanical fundamentals aptitude, with good hands on approach.
Robust communications skills, fluent English is essential, with strong writing, editing, clarity and negotiation skills.
Must have a strong attention to detail, problem solving skills, and demonstration of logic.
Candidates will have the ability to work in collaboration with others on a project team and independently on tasks.
Good PC skills with proficiency in Microsoft Office packages.
The candidate should be self-motivated and eager to learn new skills, they need to be flexible, excellent team player and demonstrate the Microchip values.

#LI-PT1

Senior Process Development Engineer

Cook Group

Limerick

30+ days ago

Limerick

30+ days ago

The primary purpose of this position is to lead a team of Engineers focused on the development of processes required to manufacture device designs which are developed by Research & Development in Cook Medical.

Reporting to: Research & Development Manager

Find out more about Cook Medical here

Lead a team of Engineers focused on identification, development, and implementation of new processes (within Cook Medical or with third parties) required for the manufacture of device designs which are developed by R&D in Cook Medical.
Ensure that a risk based approach is applied during the development implementation and validation of all processes both within Cook Medical and with third party suppliers.
Ensuring that the principle of Design for Manufacture is central to the R&D process and the devices developed within R&D.
Where appropriate apply Lean Manufacturing principles to the design and implementation of new processes.
Provide leadership and mentoring to team members to ensure their development and the effective completion of the activities associated with their role.
Work with the R&D Manager and other Senior Engineers to ensure the appropriate allocation of resources and prioritisation of efforts for the overall R&D group.
Collaborate with other R&D Teams to ensure the effective completion of all activities associated with an R&D Engineering project / objective.
Ensure effective reporting to the R&D Manager.
Work closely to build effective relationships with other functions in particular Operations, Quality and Regulatory teams.
Supplier selection, process development and validation.
Support Regulatory Affairs as required with engineering input for process related submissions and renewals prior to and post initial release of devices to market.
Ensure the effective transfer of products from other Cook entities.
Provide engineering input and support to those responsible for Supplier instigated changes.
Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles.
Responsible for process engineering layout plans and implementation in relation to new processes and production lines.
Provide engineering input and support for the investigation and resolution of Non Conformances associated with devices post release to market.
Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
Drive the Cook Medical compliance culture amongst Manufacturing Engineering team members and ensure that compliance requirements are always met.
Liaise with other Cook manufacturing facilities.
Support other cross functional groups to achieve company goals.
Benchmark systems and processes against best industry practice, modify and develop accordingly to further improve operational efficiencies.
Designee for Manufacturing Engineering Manager/ R&D Manager and Senior Test Engineer.
Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Formal Production/Engineering qualification and relevant experience in the area of NPI and/ or process development
Strong proven people management skills. Previous experience in a supervisory position desired. The ability to supervise, lead and motivate a group of talented engineering staff.
Proven project management capability in a project leader role.
Strong interpersonal skills and the ability to communicate at all levels of the organisation.
Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
Proven problem-solving skills.
Good computer skills including knowledge of Microsoft® Office.
Excellent organisational and team building skills.
High self-motivation.
Willingness and availability to travel on company business.

Senior Supplier Quality Engineer

Edwards Lifesciences

Shannon

2 days ago

Shannon

2 days ago

Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
Key Responsibilities:
• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards
• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
• Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Other incidental duties assigned by Leadership
Education and Experience:
Bachelor's Degree or Equivalent in in Engineering or Scientific field , 4 years years experience of industry experience or industry/education Required or
Master's Degree or equivalent in in Engineering or Scientific field , 3 years years experience of industry experience or industry/education Required or
Ph.D. or equivalent in in Engineering or Scientific field industry experience or industry/education
Additional Skills:
• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required (if applicable)
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of applicable FDA regulations for medical device industry
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Senior Industrial Engineer

Sigmar

Tipperary, Tipperary

5 days ago

Tipperary, Tipperary

5 days ago

This well established medical devices brand with a reputation for validation is hiring a Senior Industrial Engineer for their team.

Job Responsibilities:

Leading and championing major CI initiatives across the site.
Nurturing commitment to the vision, mission, objectives, and values of the company.
Shaping, developing, and aligning the strategies of the Operational Excellence team
Coaching functional and production leaders on the principles of lean & Operational Excellence.
Leading site Kaizen events to achieve financial or strategic objectives
Holding detailed knowledge and can teach others on all Lean tools
Proven track record in Project Management and delivery of results
Driving changes with the Product design and engineering teams.
Driving the operational Excellence strategy on-site, developing and driving new strategy, systems and tools.

Job Requirements:

Bachelors Degree or Masters in Lean / Operational Excellence (Level 8 minimum)
Previous experience in a similar role within a highly regulated environment
6 Sigma green or black belt

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

Process Development Engineer

Takeda Pharmaceutical

Ireland

2 days ago

Ireland

2 days ago

Job Description

Lead a cross-functional team during technical transfers (sending site) and new product introduction (NPI) (receiving site) projects in accordance with a pre-approved project plan, schedule and current project management best practice. Ensure that critical manufacturing systems and support structures are in place for major technology transfer and NPI projects and provide technical advice on process engineering requirements as needed. Liaise with technology transfer project counterparts in other Takeda sites;
Project manage the technical transfers to ensure a smooth transition;
Execute early stage feasibility, technical, process optimisation and process validation studies;
Liaise with the Engineering Process Support Team to identify process improvement opportunities for legacy products. Propose and implement sustainable solutions to reduce processing times, improve yield, reduce defects and eliminate waste;
Identify cost-effective opportunities for the introduction of best-in-class manufacturing technologies. Design and introduce these technologies to manufacturing operations;
Review Change Records and Risk Assessments to assess potential process and validation impact;
Use statistical software packages for data analysis and in the identification and reporting of shifts, signals and trends in process parameters and product quality attributes;
Execute process improvement projects and deviation investigations using Six Sigma methodologies;
Liaise with other departments, vendors, external consultants & other Takeda sites as required;
Provide regular progress updates (written and verbal) on projects and activities within and beyond the Manufacturing Sciences Team as stated in project communication plans and/or as required by the relevant stakeholders;
Adhere to the compliance matrix of business processes and routine departmental tasks;
Comply with the relevant industry and Company quality standards and the cGMP pertaining to pharmaceutical production;
May be required to assume responsibilities of Process Support Engineer where applicable, from time to time and as directed by the Manager or Director.

Participate fully in any cross functional training initiatives;
Drive and promote the corporate values of Takeda-ism within the workplace;
Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business;

Ensure timely completion of all SOP reading, training and assessment;

Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.

Degree qualified in a Science or Engineering discipline;
Masters in a related field is preferable.

Ideally 3 - 5 years’ experience as a Process Engineer with Pharmaceutical industry and New Product Introduction project experience;
Operations, process / technical support, projects or validation-based experience of oral solid dosage manufacturing processes an advantage;
Experience with technical transfers (sending site) for pharmaceutical products an advantage.

Excellent communication, report writing, presentation, interpersonal and time management skills.

Locations

Bray, Ireland

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time

Job Type

Contractor, Full Time

Posted

19 days ago

Description

Main Responsibilities:

Liaise with Sustaining Engineering, and other departments, to develop and introduce new products, components and processes in key supplier sites.
In conjunction with Sustaining Engineering and Supplier Quality engineering, support and advise suppliers on validation requirements as necessary.
Work with internal groups to review and assess the impact of supplier change requests, and responsibility for implementation and approval of same.
Support the assessment of non-conforming raw materials received from suppliers.
Liaise with Purchasing and Supplier Quality Engineering to improve the Quality Systems procedures relating to suppliers.
Identify and capitalise on opportunities for the reduction of cost, yield or quality improvements with existing or new vendors, via process improvement or transfer.
Assess current internal supplier processes to streamline and optimise.
Liaise with the Purchasing group to identify new suppliers as needed.
Liaise with Supplier Quality Engineering and Sustaining Engineering (CAPA) to ensure the effective completion of Supplier Corrective Actions (SCA’s)
Collaborate with Purchasing and Legal to ensure the development and implementation of effective supply agreements with suppliers.
Ensure effective reporting to the Engineering Management team.
Provide technical support and input when required to the Suppler Audit process.
Responsible for operating general internal quality systems and documentation.

Requirements:

Formal Production/Engineering qualification and relevant experience in as least one of the following areas: Manufacturing, Engineering/Device Design & Development/CAPA.
Strong interpersonal skills and the ability to communicate at all levels of the organisation.
Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
Proven Project Management and problem-solving skills.

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie