353 Medical Device Sales jobs in Ireland

• Ensure quality of process and product as defined in appropriate OS and Material specifications.
• Ensure GMPs and system safety.
• Participate in FMEA, Control Plan, SOP and PPAP generation associated with product transfers and scale ups.
• Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
• Provide training for manufacturing team members.
• Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner.
• Validation, Appraisal and support of machining suppliers and raw material suppliers.
• Communicate and participate in system and process troubleshooting with support team members and with external agents.
• Lead and participate cross functional and cross divisional process improvement initiatives.
• Provide engineering support for new Product and new process introduction, ensuring that all activities are completed and documented in accordance with Stryker New product Development Process.
• Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.
• Conduct Gauge R&R studies for products and new processes.
• Carry out structured problem solving.
• Application and development of statistical tools for use in driving continuous improvement projects.
• Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.
• All other duties as assigned.
• Level 8 Degree in Engineering, Science or related discipline or equivalent Technical experience.
• Has 0- 2 years' experience in a manufacturing environment.
• Business understanding of operations and there impacts essential.
• High level of PC Skills required.
• Flexibility essential.
• Strong communication skills with both internal and external stakeholders.
• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• The individual should enjoy working in a dynamic and results motivated team environment.
• Experience in an FDA regulated or regulated industry beneficial.
• Experience in a six sigma and Lean Manufacturing environment with proven improvement results.
• Green or Black Belt 6 Sigma qualifications.
• Ability to effectively work cross-functionally with A.O, Quality, etc.

Job Type: Full-time

Pay: €45,000.00-€70,000.00 per year

Work Location: In person

JO

Job Title:
Manufacturing / Process Engineer

Location:
Navan, Co. Meath

Industry:
Medical Device Manufacturing

About The Company
With over 40 years' experience providing advanced foam solutions to the global medical device sector, our client is a trusted partner for innovation and speed-to-market in healthcare. With manufacturing operations in Ireland and Asia, the business collaborates closely with customers to deliver customised, high-quality solutions that improve patient outcomes.

Recently acquired by a multinational leader in medical device manufacturing, the Navan site is entering a new phase of growth and development. As part of this strategy, we are now seeking a
Manufacturing / Process Engineer
to join the team.

The Opportunity
This is an excellent role for a recent graduate or early-career engineer who wants to gain broad experience in medical device manufacturing. Unlike larger multinational sites where engineers can often be confined to narrow functions, this position offers the chance to work across multiple areas of the business, driving process improvements and supporting production scale-up.

You'll have the opportunity to:

• Collaborate closely with senior leadership at the Navan site.
• Work alongside experienced teams across Galway and international locations.
• Gain exposure to advanced processes, continuous improvement initiatives, and technical problem-solving.
• Develop both personally and professionally with strong mentorship and hands-on involvement.

Key Responsibilities

• Support day-to-day production engineering activities at the Navan site.
• Work with cross-functional teams to introduce, optimise, and validate manufacturing processes.
• Contribute to continuous improvement initiatives in quality, efficiency, and cost.
• Provide technical support for troubleshooting process and equipment issues.
• Assist in the implementation of new technologies and scale-up of new product lines.
• Ensure compliance with regulatory and quality standards (ISO 13485, GMP, etc.).

Requirements

• Degree in Manufacturing, Mechanical, Biomedical, or related Engineering discipline.
• 0–3 years' experience in manufacturing, ideally within the medical device or regulated industry (placement / internship experience considered).
• Strong problem-solving and analytical skills.
• Good communication and teamwork abilities.
• Enthusiastic and adaptable, with a willingness to learn and take on a broad scope of responsibilities.

What's On Offer

• Opportunity to work in a high-growth site with global backing.
• Broad exposure to multiple functions, processes, and leadership.
• Hands-on learning and development in a collaborative, supportive environment.
• Clear potential for progression as the site expands.

If you are interested in this opportunity as the next step in your engineering career, please send your CV to
(email protected)
.

I'll review your CV and reply back within 24 hours.

JOB DESCRIPTION

Job Title:
Business Operations Lead – Medical Devices

Division:
Medical Devices

Reports to:
Director of Medical Devices

Grade:
Principal Scientific Officer (PSO)

No. of direct reports:
Team of
Assessors

Status:
Permanent

Location:
Hybrid working available with occasional attendance in Dublin office required

Reference:
56-25

Job overview

NSAI is looking to recruit for the position of Business Operations Lead – Medical Devices who will be responsible for managing a team of medical device and/or in vitro diagnostic Assessors (Product Reviewers, Auditors and Lead Auditors) and Internal Clinicians. The People Operations Partner reports into the Business Operations Lead.

NSAI is a Notified Body designated under the following Regulations and Directives:

• Medical Devices Regulation 2017/745,
• In Vitro
  Diagnostic Medical Devices Regulation (EU) 2017/746

And is recognised as:

• Medical Device Single Audit Program (MDSAP) auditing organisation

And is accredited to ISO as a Certification Body for:

• ISO 13485
• ISO 9001

Key Tasks and Responsibilities

• Identify and attend meetings for sales/marketing purposes; support sales strategy development.
• Oversee resource allocation, utilisation, and availability for certification and quality tasks, supported by the People Operations Partner.
• Manage team development, performance reviews, and objective setting.
• Ensure Assessor billability and achievement of service delivery targets.
• Monitor and report operational KPIs, risks, and target deviations.
• Set operational priorities.
• Support recruitment, on boarding, people development, talent progression, and succession planning.
• Perform 1-2-1 meetings, interim and annual reviews of performance.
• Contribute to the achievement of P/L of the Medical team globally including timely and accurate reporting, achieving the Operational targets the financial year, along with other key performance metrics. This includes all NSAI-MED.
• Responsible for contributing to the forecasting activities and analysis of utilisation for the financial year including roll out of utilisation targets to the NSAI-MED.
• Member of the NBMT, representing the Operations Team.
• Support Technical Planning and Medical Planning Team in identifying visibility of planning Operations personnel, and establishing codes that can be quoted to new clients
• Secure the Operations personnel deliver services as per contractual agreements with clients.
• Member and Chair of the Operations Management Team including timely invites, accurate and timely follow up on actions and minutes.
• Participate and / or support the technical review, vigilance review, significant change committee, Customer relationship management (CRM) implementation and / or other meetings, when required.
• Liaise with external stakeholders including Clients, Competent Authorities and those outside of the Medical Team in the NSAI, in relation to site issues, standards, product, regulatory issues or other areas that require the input of the Operations Officer.
• Support the ongoing monitoring and mentoring of the team in conjunction with the Training and Competency Handler, including ensuring that Operations personnel are calibrated, that relevant training material is developed and annual calibration meetings are performed. Including harmonising Operations personnel personnel within the framework of medical devices.
• Support the inspections by Competent Authority, and for follow-up of findings
• Support processes and procedures to be a fully compliant Notified Body at all times including during audit surveillance activities.
• Secure the Notified Body has relevant Operations personnel on duty at all times excluding Irish bank holidays.
• Other relevant/appropriate duties as requested by the Director of Medical Devices.

Qualifications and Experience

Essential:

• Successful completion of a university or a technical college degree or equivalent qualification in relevant studies such as medicine, pharmacy, engineering or other relevant sciences.
• Adequate experience in conformity assessments on medical devices under the MDR and/or IVDR or previously applicable law that should have been acquired by working in a Notified Body.
• Adequate experience in compliance assessment, particularly MDSAP and ISO 13485.
• Four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
• Minimum 2 years' experience working in a Notified Body as a site auditor and/or product reviewer. Where the experience is as a site auditor only, demonstratable awareness of Product Review, for example, training is beneficial. Where the experience is as a Product Reviewer only, demonstratable awareness of auditing, for example, training or qualification as internal auditor is beneficial.
• Knowledge of device legislation and relevant guidance documents
• Appropriate knowledge and experience of risk management and related device standards and guidance documents.
• Knowledge of the notified body's quality management system, related procedures and the required qualifications for personnel involved.
• Experience in being audited by national accreditation bodies, MDSAP regulatory authorities and/or competency authorities, and responding to findings.
• The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
• Knowledge of ISO

Desirable

• Appropriate knowledge and experience of the conformity assessment procedures laid down in the following: MDR/IVDR/MDD/AIMD/IVDD
• Lead Auditor experience in ISO 13485, ISO 9001, MDSAP, MDD, IVDD, IVDR.
• Professional experience leading and managing teams in a relevant complex and specialised environment.
• Demonstrable experience of leading high-performing teams and a proven ability to develop, coach and mentor staff.
• Experience of a range of IT systems and an excellent working knowledge of file management and quality systems.

Core Competencies

• Strong project management, financial, communication, interpersonal and teambuilding skills.
• Exceptional written and presentation skills.
• Excellent planning, organisational and administrative skills.

This job specification is intended as a guide to the general range of duties for this post. It is intended to be neither definitive nor restrictive and will be subject to periodic review with the post holder.

Department:
Engineering

Reporting to:
Head of Engineering or Director of Engineering

Direct Reports:
Yes

We are seeking a Senior Engineering Manager to join a leading manufacturing facility. This is a new headcount position created due to expansion, reflecting ongoing investment in automation and future growth.

This is a full-time, office-based role (5 days per week), offering the opportunity to lead a team of engineers, drive technical capability, and play a key role in delivering new product introductions, continuous improvement, and operational excellence in a high-volume, regulated environment.

Objectives of the Position

• Lead and manage a team comprising of Engineers and Technicians within the Engineering Department.
• Develop departmental technical capability in line with customer needs.
• Enhance the capability and effectiveness of the team.
• Deliver on goals and targets to meet customer demand requirements.
• Drive cross-functional programs supporting continuous improvements in quality, delivery, and cost.
• Contribute to plant-wide projects.
• Lead and support projects and new installations as required.
• Support the plant in delivering on customer demand and new products.
• Develop succession, training, and yearly goals and plans for direct reports.
• Support and lead corporate initiatives as required.

Key Responsibilities

• Oversee manufacturing, test, automation, and preventative maintenance activities.
• Deliver on plant goals and customer needs.
• Lead and support new product projects.
• Provide customer support as required.
• Set direction and goals for a diverse team.
• Develop skills and competencies to enable the department to meet customer expectations.
• Ensure all processes are designed to comply with industry standards and health & safety regulations.

Quality & Health & Safety

• Ensure ongoing compliance with quality and industry regulatory requirements.
• Ensure compliance with health & safety legislation and regulations.

Performance Measurements

• Machine/process uptime and throughput.
• Process yield.
• Development of procedures and processes.
• Completion of tasks/projects against set objectives.
• Completion of identified training programmes.
• Availability of training and succession plans for the team.

Candidate Requirements

Essential:

• Degree in Engineering (Level 8).
• Strong management and leadership capabilities.
• Minimum of 8 years' experience in a similar role within a medium/high-volume multinational manufacturing organisation.

Desirable:

• Strong technical process knowledge.
• Teamwork and stakeholder management skills.
• Excellent problem-solving capabilities.
• Experience in medical devices.
• Excellent communication and influencing skills.
• Ability to manage and improve the performance of a diverse team.
• Strong leadership capabilities.
• High degree of initiative and accountability in achieving objectives.

Department:
Engineering

Reporting to:
Head of Engineering

Direct Reports:
None

We are seeking a Senior Automation Engineer to join a leading manufacturing facility. This is a new headcount position created due to expansion, reflecting ongoing investment in automation and future growth.

It is a full-time office role (5 days per week), offering the opportunity to lead automation projects, support new product introductions, and collaborate with both customers and internal teams.

Key Responsibilities

• Lead automation projects from requirements gathering through to full-scale production.
• Develop automation systems for new and existing products.
• Collaborate with business development, design, and production teams to support new business and product launches.
• Provide Design for Manufacturing (DFM) input on new product developments.
• Work with customers and potential customers to promote automation solutions.
• Stay current with the latest automation technologies and introduce them to the site.
• Support problem-solving and issue resolution on production lines.
• Apply Lean Manufacturing practices to improve efficiency and reduce waste.
• Ensure compliance with quality standards, industry regulations, and Health & Safety requirements at all times.

Essential
What We're Looking For

• Degree (Level 8) in Engineering (Mechanical, Mechatronics, Automation or related).
• 5+ years' experience in a design or project management engineering role in manufacturing or equipment build.
• Experience in Design for Manufacturing (DFM).
• Strong equipment knowledge with proven troubleshooting skills.
• Excellent communication and influencing skills.
• Customer-facing experience.
• Good Knowledge of some of the following: PLC programming, pneumatics, robotics, assembly techniques, label applicators, laser marking, tooling design.

Desirable

• Six Sigma Green Belt.
• Lean implementation experience.
• Project Management qualification.

Location: Galway (On-site)
Industry: Medical Device / Start-up
Our client, a dynamic and fast-paced medical device start-up based in Galway, is seeking a Quality Engineer I to join their growing team. The company is focused on developing innovative, patient-centric technologies to improve quality of life and is advancing rapidly through the product development lifecycle toward global market launch.

This role offers a unique opportunity for a motivated and hands-on quality professional to apply their engineering knowledge across multiple areas of a developing Quality Management System. The ideal candidate will enjoy working in a cross-functional, start-up environment and contributing directly to impactful product development.

Responsibilities include but are not limited to the following:

• Apply quality engineering expertise across the Quality Management System (QMS).

• Support certification and maintenance of compliance to ISO 13485 and 21 CFR Part 820.

• Assist with design assurance activities, including design controls, verification, and validation.

• Support development and validation of test methods and computer system assurance programs.

• Participate in risk management and usability engineering activities.

• Maintain document control through QT9 eQMS and perform related administrative tasks.

• Contribute to the CAPA and non-conformance (NC) investigation and resolution process.

• Assist in internal and external audits and implement corrective actions as needed.

• Support updates and gap assessments for applicable regulatory standards and guidance.

• Participate in supplier quality management, vendor evaluation, and AVL maintenance.

• Collaborate cross-functionally to uphold quality objectives and continuous improvement.

• Perform additional quality-related duties to support business goals and KPIs.

• Bachelor’s degree in engineering, science, or related field (or equivalent).

• Minimum of 2 years' experience in a medical device or supplier environment.

• Familiarity with ISO 13485, FDA QSR (21 CFR Part 820), and GMP requirements.

• Experience in both FDA and European regulatory environments is preferred.

• Strong initiative, problem-solving, and follow-through in executing responsibilities.

• Understanding of risk management methodologies (ISO 14971).

• Experience with sterilization (EtO/Gamma), biocompatibility, and transportation testing is a plus.

• Prior involvement in audits or inspections is an advantage.

• Proficiency in MS Office and familiarity with electronic QMS tools.

Immediate interviews available for suitable candidates.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other future vacancies

 Pale Blue Dot® Recruitment

The Experts in STEM Workforce Solutions

Senior Principal NPD Engineer – Medical Devices

Galway, Ireland (On-site, 4 days per week)

We are seeking a
Senior
Principal NPD Engineer
to join a global leader in medical technology, working on next-generation solutions that transform patient outcomes in the treatment of cardiac arrhythmias. This is an opportunity to contribute to life-changing innovation while developing your expertise in a highly regulated, fast-paced industry.

About the Role

As a key member of this new team for the Galway site, you will:

• Collaborate with R&D in the development of test methods and lead test method validation (TMV) strategies.
• Ensure TMVs, design verification, and shelf-life protocols meet required standards and regulatory compliance.
• Work cross-functionally with engineering and manufacturing to maintain and improve quality standards.
• Apply reliability engineering techniques (e.g., FTA, failure trending, forecasting) to assess product and process robustness.
• Contribute to risk management activities in alignment with FDA, ISO 14971:2019, and ISO 13485:2016 requirements.

What We're Looking For

• Level 8 Degree in Engineering or relevant discipline (advanced degree desirable).
• 8–10+ years' experience in Quality, Reliability, or related functions within a regulated industry (medical devices preferred). Candidates with a mix of NPD and exposure to manufacturing would be a good fit for this role.
• Strong knowledge of reliability tools and practices across requirements, design, integration, and validation.
• Proven ability to collaborate across complex, matrixed organizations.
• Excellent communication skills with the ability to influence stakeholders at all levels.
• Critical thinker with a focus on improved system performance and business impact.

What's on Offer

• Competitive salary and flexible benefits package.
• The chance to work with innovative technologies that improve lives worldwide.
• A collaborative, supportive environment with opportunities for growth and career development.
• On-site role at a state-of-the-art facility in Galway, with strong cross-functional teamwork.

If you're passionate about quality, reliability, and making a real impact on patients' lives, this role offers both challenge and reward.

***

For a confidential discussion and more information on the role, please contact

Location: County Tipperary (On-site)
Contract: 12-Month Fixed Term (with potential for extension)

Our client, a well-established engineering firm, is seeking a Tooling & Equipment Design Engineer to support the development of custom tooling and mechanical systems for implantable medical devices. The role is based on-site at a world-class manufacturing facility in County Tipperary. This is a hands-on, technically challenging role ideal for an experienced mechanical engineer who enjoys precision design, collaboration, and seeing their work make a real-world impact.

Responsibilities include but are not limited to:

• Design and develop mechanical tooling, fixtures, and assembly equipment to support advanced medical device manufacturing.

• Create detailed 3D models and engineering drawings using CAD (preferably SolidWorks).

• Collaborate with manufacturing, quality, and product development teams to ensure seamless integration of new equipment and processes.

• Participate in design reviews, technical problem-solving, and continuous improvement initiatives.

• Liaise with external vendors, suppliers, and equipment manufacturers to ensure quality and timely delivery of components.

• Support the validation and qualification of new equipment and processes as required.

• 3+ years of mechanical design experience, ideally in tooling, fixtures, or automation within a medical device or regulated manufacturing environment.

• Strong proficiency in CAD (SolidWorks preferred).

• Solid understanding of mechanical engineering principles, materials, and production techniques.

• Proven ability to deliver detailed and accurate mechanical designs within project timelines.

• Excellent problem-solving skills and attention to detail.

• Strong communication and teamwork skills.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

 Pale Blue Dot® Recruitment

The Experts in STEM Workforce Solutions