דרושים Senior Total Reward Analyst Months Fixed-term ב-Boston Scientific ב-אירלנד

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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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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Job Purpose:

Supervises, leads, and provides technical direction to a group of technicians and/or engineers. Devotes a portion of time contributing to managerial, leadership, technical coaching, and staff development responsibilities.

Key Responsibilities:

• Develops and enhances cross-functional team relationships and works cross-functionally to identify and resolve technical and organizational issues.

• Supervises a group of Engineers, Technicians, and contract staff.

• Determines appropriate contract staff levels in order to meet current workloads.

• Monitors spending so as to ensure department budgets are achieved.

• Provides guidance and training to staff, motivates individuals to achieve results, and assists staff in attaining performance/training objectives and career goals.

• Ensure Tooling/Equipment complies with EH&S requirements.

• Ensure best design practices/tools are employed by the group so as to maximize tooling/equipment effectiveness.

• Communicates the company, site, and department vision(s) to assure that staff objectives are aligned with the vision(s).

• Leads training and development of others; cross-functionally.

• Demonstrates TDP/PDP system knowledge through coaching and delivery of high quality, high impact deliverables. Leads documentation & development of all design requirements of developed designs or processes

Education & Experience:

• Hons bachelor’s degree in engineering or relevant discipline.
• 5+ years relevant experience.
• Competent in High Volume Automated assembly processes with the ability to provide technical guidance to more junior engineers on their systems in the VS.
• Strong working knowledge of HMI's, Vision systems (Cognex/Keyence), Electric Drives and Controls, Sensors, solenoids, printers, robots (calibration, homing, troubleshooting). All based upon an excellent mechanical aptitude foundation.
• Demonstrate ability to Innovate & influence high volume automated assembly process/technology strategy for the VS.
• Anticipates potential issues/risks and mitigates before they appear. Instill a proactive environment where all engineers and technicians are consistently monitoring their processes, know which levers to look out for to ensure the systems achieve the required uptime & yield targets.
• Technical Drawings – very strong knowledge of GD&T, dimensional criteria understanding.
• In depth knowledge of BMRAM, VIP, MES, GLS, MRB, NCEP, CAPA, Windchill, GMP.
• Acts as a technical advisor to middle management on specialized business projects and technologies.
• Technical Leadership presence, Lead by example - demonstrate best practices consistently - Essentials & Behaviour’s.
• Problem Solving leader for the VS (Minimum green belt, Black belt preferable).
• Statistical Analysis skills e.g. DOE, T-test.
• Demonstrated Stakeholder Management.

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Key Responsibilities:

• Perform and Co-ordinate risk assessments for manufacturing equipment built internally by the equipment group.
• Assessment of equipment for electrical and functional safety compliance.
• Support Mechanical and Electrical Design engineers in the design of appropriate safety systems and safety architecture.
• Safety control system reviews and calculations to ensure compliance to CE standards (e.g. ISO 13849).
• Compilation of CE marking technical file documentation.
• Ensuring equipment meets appropriate safety standards and requirements.
• Support ATEX and FMEA assessments of new manufacturing processes.
• Generation of detailed reports documenting any safety issues found (e.g., touch proofing in electrical cabinets, machine guarding issues, etc.)
• Provide input into equipment redesign for electrical and functional safety remediation.
• Provide technical leadership on equipment safety related product and process issues.
• Work closely with internal engineers to understand safety equipment requirements.
• Work closely with internal and external machine build to ensure that equipment is built according to site safety specifications and is properly handed over to manufacturing.
• Review of safety of external vendor-built equipment.
• As the Safety Team Lead, this person is expected to work closely with both internal and external specialists to complete equipment related projects.
• Provide reports to senior management on equipment safety incidents.

Education & Experience:

• Level 8 Honors Degree in Engineering or EH&S discipline essential.
• Ideally electrical background.
• 5+ years experience in a similar role particularly with experience CE Marking equipment.
• Machine safety qualifications such as CMSE (Certified Machinery Safety Expert) or CECE (Certified Expert in CE Marking) desirable.
• Strong communication, organisational and interpersonal skills combined with an imaginative and creative approach to problem solving.

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