Senior Planner jobs at Boston Scientific in Ireland

Key Responsibilities:

• Leads, develops, and empowers the Galway Supplier Quality team to deliver exceptional results through coaching, mentoring, and talent development initiatives.
• Serves as the primary representative for Global Supplier Quality at the Galway site, ensuring alignment with global sourcing strategies, corporate objectives and on the Regional Supplier Quality Management team.
• Provides strategic direction on supplier quality programs, driving excellence in supplier performance, compliance, and continuous improvement.
• Builds and sustains strong partnerships with suppliers, internal manufacturing, and cross-functional stakeholders to achieve business and quality goals.
• Maintains accountability for product quality decisions, including the assessment and disposition of non-conforming materials from suppliers.
• Champions a culture of continuous improvement, fostering innovation and operational excellence across supplier quality processes and systems.
• Demonstrates effective change leadership, proactively managing transformation initiatives to strengthen quality performance and supplier collaboration.
• Monitors and reports key supplier quality metrics and trends, implementing data-driven actions to mitigate risk and improve overall supplier capability.
• Acts as a key contributor in supplier audits, escalations, and customer complaint investigations, ensuring timely resolution and systemic corrective actions.
• Promotes an inclusive, entrepreneurial work environment that empowers team members and reinforces Boston Scientific’s vision, values, and commitment to patient safety and quality.
• Drive compliance with Quality Policy and Supplier Quality standards.
• Lead and develop a professional team, set priorities, allocate resources, and establish operating policies.
• Resolve complex technical and organizational issues; develop and implement solutions with broad impact.
• Influence decisions internally and externally; communicate technical information in clear business terms.
• Accountable for business results, project planning, and achievement of SQP-level goals through leadership and mentorship.

Education & Experience:

• Level 8 Honors Bachelor’s Degree in a technical discipline such as Science or Engineering. (STEM)
• Minimum of 8 years’ experience in manufacturing operations, supplier quality, or engineering, including people management and leadership responsibility.
• Proven record of leading teams, with demonstrated ability to build high-performing, inclusive, and accountable organizations.
• Strong technical foundation with, demonstrated logical decision-making focused on product quality and patient safety.
• Demonstrated ability to manage and influence internal and external stakeholders, to drive alignment and commitment

Key Responsibilities:

• The ability to perform failure analysis on electronic test equipment.
• Using knowledge of standard system software applications, able to work with in-house and external software developers to define and drive improvements and changes to test applications and systems to improve manufacturing test yields.
• Work with cross functional groups to improve product quality, lean efficiencies and test system efficiency’s and reduction in production fallout.
• Performs tests, writes reports and executes validations to medical device standard for Test and Manufacturing processes.

• Excellent data analysis and technical problem-solving skills and project time management
• Utilizing good documentation skills, complete regulatory submissions using change notice process and procedures.

• Work daily with quality, manufacturing, R&D and Design to efficiently implement product transfer.
• Work with PM to develop manufacturing project timelines.

Education & Experience:

• Hons BSc degree in electrical engineering or related discipline.
• 5+ year’s relevant experience in a related industry.
• Experience in an electrical engineering-related environment essential.
• Strong working knowledge of process validations with proven problem-solving abilities and the ability to project manage issues to closure.
• Knowledge of test software applications such as Lab View and C or C++
• Experience in validations in the medical device industry and new product transfers would be an advantage.

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Job Purpose:

You will provide support for both new and current manufacturing equipment in regard to design, installation, troubleshooting, performance and validation activities.

Key Responsibilities:

• Generate documentation for the detailed specification, design, development and testing of new equipment & automated systems

• Develop detailed knowledge & understanding in all aspects of automation systems including PLC, HMI, vision, robotics, PC software and databases.

• Develop a detailed understanding of Overall Equipment Effectiveness (OEE) and use of same to drive optimum equipment utilisation/operation.

• Identify equipment & automated system upgrades as part of continuous improvement programs, improving equipment/systems in terms of performance, qualify & availability.

• Provide technical support and make informed decisions on hardware and architecture selection

• Analyse, understand & fault-find as necessary on complex automation equipment

• Develop, test and install code changes to existing equipment under change control

• Maintain comprehensive documentation of code to medical device standards

• Actively participate among cross-functional teams to ensure projects are delivered on time and to required quality standards.

Education & Experience:

• Degree in Automation/Electrical/Electronics/Mechatronics/Software or related Engineering discipline with at least 5 years relevant experience

• Experience working with automation systems & automated production equipment essential
• Excellent working knowledge of PLCs: Allen Bradley, Siemens, Beckhoff, GE Fanuc, Mitsubishi, Omron, Toshiba etc.
• Experience of HMI or SCADA programming and configuration

• Hands-on working experience with Allen Bradley and Siemens PLC’s a distinct advantage.
• Hands-on working experience with Robotics & Vision system applications is an advantage
• Excellent analytical and Technical problem-solving skills essential
• Strong organisational skills

• Strong Leadership & Influencing skills
• Works well within a team environment and on own initiative

• Ability to document own work clearly and precisely

• Excellent communication skills

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Job Purpose:

The Senior Regulatory Affairs (RA) Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. Additionally, the Senior RA Specialist is responsible for assessment of device changes for regulatory implications.
This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Cork, Galway or Clonmel. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Key Responsibilities:

• Develop US, EU and international regulatory strategies for approval of medical devices
• Coordinate, compile, and submit U.S. and EU regulatory filings for new and modified products
• Support requests from BSC International Regulatory personnel related to submissions, registrations, and change assessments
• Develop and maintain positive relationships with regulatory body reviewers
• Review Technical and Labelling documentation for inclusion in regulatory filings
• Review product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Represent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement efforts
• Review clinical study protocols and other clinical documentation, and assess clinical study related changes to determine regulatory impact
• Support regulatory audits, as required
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Required:

• A minimum of a Level 8 Honours Bachelor's Degree in STEM
• A minimum of 5 years of regulatory affairs or related experience
• Demonstrated experience assessing product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as 510(k)s and MDR Technical Documentation
• Basic computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred:

• Strong technical, research and problem-solving skills
• Ability to articulate complex ideas clearly both verbally and in writing
• Team player with excellent interpersonal skills
• Demonstrated ability to effectively manage multiple projects and priorities
• Works well in fast-paced cross-functional team environments
• Pharmaceutical and/or Drug/ Device Combination device experience and Clinical expertise an advantage

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ployees with a disability. Should you require a reasonable accommodation during the recruitment process, please email

Job Purpose:

on our, you’ll be the technical driver behind product quality, reliability, and lifecycle improvements across a portfolio that includes laser fiber devices for kidney and bladder stone treatment (lithotripsy) and prostate tissue removal (HoLEP). You’ll lead crossfunctional work that keeps our devices safe, effective and available—so patients get the care they need, when they need it. *Your way forward is our way forward".

Key Responsibilities:

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Job Purpose:

As a Senior R&D Engineer, you will be responsible for providing
electrical and electronic engineering support and expertise in the definition, design, development and test of medical device products with a particular emphasis on catheter-based ablative therapies such as Renal Denervation (RDN).

This is a leading role in design and troubleshooting of mixed hardware/software systems associated with SUD devices, ensuring compliance with regulatory and safety standards, and contributes to innovation and intellectual property development, enabling safe, effective, and differentiated therapy delivery systems.

Key Resposponsibilities:

• Designs, develops, debugs, modifies, tests electrical circuits and systems for therapeutic ablation catheters and consoles, using current tools, analysis techniques, and technologies.
• Leads troubleshooting and root cause analysis of electronic test failures, driving solutions to component/system level.
• Develops, tests, and characterizes new catheter prototypes and console interfaces from concept through launch in cross-functional teams.
• Analyzes, evaluates, and verifies requirements, circuits, and systems using engineering practices; ensures integration of hardware, firmware, and physiological signal acquisition.
• Investigates, researches, and selects electronic circuits, components, tools, equipment, and practices for advanced ablative therapy devices.
• Documents electrical development through protocols, technical reports, memos, change requests, and design history files, per BSC quality system standards.
• Ensures compliance with medical device safety and EMC standards (e.g., IEC60601 series).
• Mentor junior engineers and technicians; provides technical leadership, feedback, and training to build high-performance teams.
• Translates high-level clinical requirements into robust engineering solutions and identifies opportunities for product innovation and intellectual property.
• Communicates technical updates at weekly team meetings, risks, and milestones to project leaders and senior stakeholders
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the BSC Quality Policy.

• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Required:

• Level 8 Honours Bachelor Degree in Electrical Engineering.
• 5+ years of experience in medical devices or other highly regulated industries, preferably with catheter-based or implantable systems.
• Hands-on expertise in circuit/system design, system troubleshooting, and root cause analysis.
• Proven experience with regulatory/safety standards (IEC60601 series, EMC).
• Strong communication, documentation, and project management skills.

Preferred:

• Experience with ablative modalities (RF, ultrasound, IVL, PFA).
• Familiarity with firmware debugging, digital logic, FPGA, and system integration.
• Data analysis (LabVIEW, MATLAB, Python) and automated test development.
• Experience in intellectual property development (patent drafting, disclosures).
• Demonstrated ability to mentor and lead cross-functional teams.

Key Responsibilities:

• Lead electronics designs from concept to production
• Become a Subject Matter Expert (SME) for design of external electrical medical equipment for new product development projects as well as sustaining engineering and value improvement projects
• Analyze and assess technical reports and other information to make recommendations for electronic components and design approaches
• Continuously improve processes and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow and work processes
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
• Must have good communication and interpersonal skills
• Provide Technical support, as required, to technology and product development teams
• Must be a self-starter, manage own time and prioritize tasks based on business priorities
• Ability to delegate tasks of larger projects across a development team
• Previous experience in the technical mentorship of junior engineers

Education & Experience:

• Hons bachelor’s degree in electronic, computerengineering or equivalent
• +5 years’ experience in the medical device industry or other similarly regulated field

• Experience working with international standards such as IEC 60601 and IEC 61000

• Strong communications and time management abilities
• Strong technical knowledge of electronic design including electronic simulation, schematic capture, and PCB layout
• Experienced in design of drive and control electronics for DC, stepper, and BLDC motors.
• Lab skills and experience with debugging, prototyping, general test equipment setup for electronic designs.
• Experience in designing to solve and mitigate EMC issues
• Deep understanding of requirements adherence principles (product specifications, etc.)
• Prior experience working with external vendors.

Preferred Qualifications

• Master’s degree in a relevant field
• Experience as a technical leader in more than one project
• Familiarity with design for manufacturing (DFM) and design for test (DFT)

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