Senior Supervisor Design Quality Assurance jobs at Boston Scientific in Ireland, Galway

Job Purpose:

As an experienced Quality Engineer, you will demonstrate commitment to the Quality Policy (patient safety and product quality) through daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Committed to patient safety and product quality.

Key Responsibilities:

• Takes a preventive approach to Quality Assurance, proactively identifying potential issues.
• Uses strong organisational skills and effective time management to ensure work is completed in a timely manner.
• Effectively prioritises a diverse workload to ensure timely completion of critical tasks.
• Plans and executes both daily tasks and long-term projects to ensure timelines are met.
• Takes a pragmatic and logical approach to challenges faced.
• Explains technical topics clearly to diverse stakeholders through effective communication.
• Promotes a culture of continuous improvement through reflection and factoring in previous learnings.
• Makes informed decisions related to product quality, including dispositioning non-conforming product.
• Evaluates complex quality issues and selects the most appropriate problem-solving tools/ techniques.
• Completes timely scoping and containment of product-related issues when required.
• Documents non-conformances using a high standard of technical writing and detailed understanding of Containment, Disposition, Risk Assessment and Investigation.
• Identifies and drives Corrective Actions when required, to prevent/ eliminate/ facilitate/ mitigate the re-occurrence of non-conformances.
• Reviews Complaints’ signals and completes investigations for individual events/ unfavourable trends.
• Familiar with BSC Quality Systems and ISO/MDD/MDR standards.
• Involved in internal and external audits, including audit facing and presenting processes/ documents to auditors as a subject matter expert.
• Knowledgeable on Risk Management, Design Outputs and product/ process Risk Documentation.
• Uses appropriate statistical tools for sampling, capability, trend analysis, and control charts. Effectively interprets and presents conclusions drawn.
• Participates directly in a new product/technology transfer, ensuring compliance to all internal and regulatory requirements.
• Uses knowledge of Six Sigma, Statistical Analysis and Lean Principles to solve problems effectively.
• Involved in change control for work instructions, protocols/ reports and technical documents, either as a change owner or quality approver.
• Evaluates new equipment/processes/chemicals for safety and environmental impact/effect, in conjunction with EH&S.
• Completes validations for processes/ test methods in line with requirements and best practices.
• Maintains relationships and gives technical guidance to Quality Technicians.
• Deals with suppliers, other engineering disciplines within and outside of the site as required.

Education & Experience:

• A Level 8 Degree (240 Credits) or equivalent in a STEM discipline.
• A minimum of 5+ years relevant experience, ideally within the Medical Device industry or another highly regulated environment.

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Job Purpose:

You will demonstrate commitment to the Quality Policy (patient safety and product quality) through your daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Committed to patient safety and product quality.

Key Responsibilities:

• Takes a preventive approach to Quality Assurance, proactively identifying potential issues.
• Uses strong organisational skills and effective time management to ensure work is completed in a timely manner.
• Effectively prioritises workload to ensure timely completion of critical tasks.
• Plans and executes daily tasks to ensure timelines are met.
• Takes a pragmatic and logical approach to challenges faced.
• Explains technical topics clearly to diverse stakeholders through effective communication.
• Promotes a culture of continuous improvement through reflection and factoring in previous learnings.
• Makes informed decisions related to product quality, including dispositioning non-conforming product.
• Evaluates complex quality issues and selects the most appropriate problem-solving tools/ techniques.
• Completes timely scoping and containment of product-related issues when required.
• Documents non-conformances using a high standard of technical writing and detailed understanding of Containment, Disposition, Risk Assessment and Investigation.
• Identifies and drives Corrective Actions when required, to prevent/ eliminate/ facilitate/ mitigate the re-occurrence of non-conformances.
• Familiar with BSC Quality Systems and ISO/MDD/MDR standards.
• Involved in internal and external audits, including audit facing and presenting processes/ documents to auditors as a subject matter expert.
• Knowledgeable on Risk Management, Design Outputs and product/ process Risk Documentation.
• Involved in change control for work instructions, protocols/ reports and technical documents, either as a change owner or quality approver.
• Maintains relationships and gives technical guidance to Quality Technicians.
• Deals with suppliers, other engineering disciplines within and outside of the site as required.

Education & Experience:

• A Level 8 Degree (240 Credits) or equivalent in a STEM discipline.
• A minimum of 3+ years relevant experience, ideally within the Medical Device industry or another highly regulated environment.

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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

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.

Job Purpose:

You will demonstrate commitment to the Quality Policy through your daily execution of sound quality practices and the maintenance of an effective quality system and complying with regulations governing the quality system. You will ensure your team are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

Key Responsibilities:

• Lead a group or team of employees in the achievement of organizational goals.
• Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
• Assure that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establish and promote a work environment which supports the Quality Policy and Quality System.
• Select appropriate techniques for problem solving and make solid and consistent Engineering and Quality Assurance recommendations.
• Have the responsibility and authority to make decisions related to product quality including the disposition of non-conforming product.
• Demonstrate and actively promote highest level of professional QA Engineering discipline and rigor.
• Be a leader in QSR, ISO / MDD standards within your group, be constantly aware of best industry practices.
• Have significant expertise in validation engineering and be familiar with all regulatory requirements.
• Champion continuous improvement and innovation from a quality perspective within the department.
• Provide technical guidance to Quality Engineer and Quality Technicians.
• Build quality into all aspects of work by maintaining compliance to all quality requirements.
• Promote the attainment of group goals by selecting, motivating, and training capable staff.
• Monitor progress toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility.
• Provide direction and guidance to experienced professional employees.
• Act as an adviser to professional employees and may become actively involved, as required, to meet schedules and resolve problems.
• Evaluate performance of and assist in career development planning for subordinates.
• Work under minimal supervision. Independently determine and develop approach to solutions.
• Create immediate to mid-range plans to carry out objectives established by top management.
• Interview and recruiting new team members as needed.

Education & Experience:

• A Bachelor Degree Level 8 (240 credits) of Engineering, Sciences or equivalent experience.
• 5-8 years’ Quality Assurance/Engineering experience in the Medial Device / Combination Product (Highly regulated environment)
• Experience with new product introduction and project management is advantageous
• Team player with strong work ethic and positive mentality
• Strong written & verbal communication skills, with excellent stakeholder management.
• Strong technical knowledge & understanding of product design.
• People management experience is advantageous.

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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Costa Rica-Coyol

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)