Senior Legal Counsel jobs at Boston Scientific in Ireland, Galway

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:

• 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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Hybrid Roles:

Your responsibilities include:

• May execute the following resposibilities:Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
• Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs.
• Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.
• Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development
• Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Evaluates new equipment and processes and participates in the transfer of new products.
• Get involve in various stages of equipment and processes validations: Run and / or review and / or approve reports I.Q 's, O.Q' s and P.Q 's as well as any other document relating to validation.
• Read and interpret technical drawings, procedures, and protocols
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
• Document investigation findings in analysis report on GCS2
• Become a trainer for the Software related with complaints handling process (GCS2), as required.
• Work with Research and Development to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities
• Provide supervision, leadership, and overall direction to the Quality Release team to ensure they are identifying issues, quarantining defective product, and efficiently moving product through the release process. Clarify priorities and remove roadblocks to maintain a high level of quality in accordance with ISO standards, cGMP's, Corporate and site level SOP's.

Minimum Required Qualifications

• Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field
• 2+ years of experience as Quality Engineer
• English Level B2 (advanced)

Key Responsibilities:

• Co-ordinate and consolidate the month end results for the Site. Provide variance analysis to forecast and annual Plan and help co-ordinate the preparation of the executive summaries that are provided to Leadership team on Site and executive team in US.
• Coordination with global business services, divisional finance teams & local finance team to ensure efficient and effective month end close.
• Co-ordinate and Consolidate the Forecast Quarterly and Annual Operating Plan submission for the Site, and also communicate variance analysis to the Leadership team on Site and help co-ordinate the preparation of the executive summaries that are provided to Leadership team on Site and executive team in US.
• Prepare and consolidate the monthly balanced scorecard summaries (Key Site Metrics) for the Site for the month with key executive level summary. Work closely with the finance team and Leadership team to provide insightful commentaries.
• Business Partnering – Provide financial support to your specific business area through comprehensive review of their financial performance, lead forecast & budgets for their area & provide financial appraisal support with emphasis on HC planning and Overhead Spend analysis
• Maintain effective control systems for areas under your responsibility ensuring full compliance with Corporate Policy, SOX & GAAP.
• Support projects depending on Finance & Business priorities.
• Support the FP&A Senior manager on ad-hoc projects that help drive process improvements.

Education & Experience:

• Level 8 Honors Bachelors Degree in Finance, Business or relevant discipline
• Qualified Accountant ACA / ACCA / CIMA / CPA with 5+ years post qualified experience.
• Experience in a fast paced manufacturing environment would be a distinct advantage.
• SAP experience is an advantage
• Expert level financial system & excel skills are essential.
• Strong analytical & interpersonal skills.
• Aptitude for identifying & implementing process improvements

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Key Responsibilities:

• Advise leaders in our three Irish manufacturing sites on strategic and operational matters, providing practical, solution-oriented guidance and risk analysis;
• Support the Indirect Sourcing team to negotiate and conclude high-value supplier agreements covering a wide range of services and equipment;
• Work with Facilities and Site Services on real estate transactions, including acquisitions of land and buildings, negotiation of leases/licenses, planning applications, and related matters;
• Partner with Global Compliance and our local Compliance Specialists to drive our Compliance Program within Ireland;
• Triage employment law issues and find solutions in conjunction with the Global employment law team and/or external counsel;
• Advise on internal investigations, including relating to legal professional privilege;
• Collaborate with others in the Global Legal Department on matters pertaining to M&A/integrations, Data Protection, ESG, Product Liability and RA/QA;
• Develop/maintain efficient legal processes and templates that appropriately mitigate risk;
• Keep current on legal developments and impart knowledge to collegues by delivering training and communications;
• Participate in special change projects or EMEA / Global initiatives;
• Instruct and manage outside counsel in a cost effective manner

Education & Experience:

• Qualified to practice law in Ireland with 7 or more years of local post-qualification experience.
• Experience of a manufacturing environment and sourcing/procurement
• Experience in life sciences or another regulated sector and public law (including public subsidies and government funding) would be a plus but is not a mandatory requirement
• Comfortable working directly with senior, high-energy, innovative business clients
• Energetic self-starter that can operate and make decisions autonomously
• Clear and concise communicator (verbally and in writing)
• Ability to triage and prioritize workload
• Committed to fostering an inclusive and positive working culture within the company
• Able to travel to all three site in Ireland as needed and occasionally (less then 10%) internationally

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