Associate Project Manager jobs at Boston Scientific in Ireland, Galway

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

About the role

The ideal Principal Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative electrophysiology cardiovascular products portfolio. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.

Your responsibilities include:

• Lead Quality function for product development teams within the BSC Quality System to develop new Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES) as part of a core group of Design Quality Assurance (DQA) Engineers.
• Provide quality and compliance inputs to project teams for project decisions and deliverables (i.e. Design Change Analysis; Design Inputs, Design Outputs; Test Method Development and Validation; Design Reviews; Design Verification and Validation; Usability Testing; SW Validation; Process Validation; and Labeling).
• Provide quality and compliance inputs for post market product sustaining activities, such as design changes, Non-Conformance Reports (NCEP); Corrective and Preventive Actions (CAPA’s); Product Inquiry Report/Field Action Assessment (PIRs); Field Signals Evaluations and Field Actions.
• Lead Risk Management processes for new products with key inputs from cross-functional product development teams (i.e. Risk Management Plan, Risk Management Report, Risk/Benefit Analysis, Hazards Analysis, dFMEA, pFMEA, etc.)
• Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME).
• Lead NPD projects as a DQA SME and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
• Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements.
• Support internal and external regulatory audits as required.
• Other duties as necessary or required by the organization.

what we're looking for in you:

Required Qualifications

• B.Sc in Biomedical, Electrical Engineering or equivalent.
• 10 years of medical device engineering experience, with experience inMedical Electrical Equipment/Systems (MEE / MES).
• Applied knowledge in the verification and validation of Capital Equipment, including hardware, software, firmware, and systems of systems interdependencies.
• Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971, IEC 62304 and EN ISO 13485.
• Strong leadership, relationship building, and team building skills.
• Demonstrated ability to mentor and coach others in analysis and risk based decision-making processes to balance business and compliance needs.
• Strong communication and presentation skills.
• Strong applied knowledge of statistical concepts, tools, and methodologies.
• Travel approximately 5-10%.

Preferred Qualifications

• Experience with Software as a Medical Device (SaMD) and/or systems integration

Maximum Salary: $ 197000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

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.

Job Purpose:

As an, you will have the opportunity to work on a range of projects including leading a product or technology development project, moderate-sized Site Transfer / Acquisition projects, and a site representative for broader Global projects as required.

Key Responsibilities:

• Lead medium/large sized cross-functional development teams.
• Provide input to functional managers on the team and team member performance. Influences & satisfies key project stakeholders through each phase of the project.
• Manage the technical challenges of technology application and new product development; proactively identifies, communicates and manages technical risk engaging the key subject matter experts in this process.
• Develop and implement the project plan proactively identifying risks and embedding appropriate mitigations into plans
• Build team ownership and commitment to the project plan outlining clear decision points Presenting options & recommendations to decision-makers supporting data/rationale.
• Develop and control the project budget throughout the project lifecycle.
• Follow the appropriate applicable project roadmap (e.g. PLCP process for NPI, Product Transfer roadmap for Site Transfers etc.) and represent Operations on the overall Core Team; lead the Operations team to complete all activities to current policies and practices & represents same at all phase reviews.
• Responsible for team and cross-functional communications ensuring appropriate communication is maintained throughout the project with key stakeholders and specific issues/decision points are communicated in a timely manner.
• Ensure the communication is tailored for the audience from Project Team reviews right through to Senior Leadership reviews. Lead phase and business reviews, project meeting minutes, issues log, metrics, and other key communications.

Education & Experience:

• Level 8 Honors Bachelors degree (240 credits) in a Technical discipline (e.g. Engineering, Science, Software, Manufacturing); a Qualification in Project Management and/or a Level 9 (Masters) would be an advantage.
• 5+ years of project management in an Operations or New Product Development environment
• Strong experience in project managing larger-scale / complex projects involving multiple functions (e.g. Divisional R&D, Program Management, Regulatory Affairs, Design Assurance, Process Development, Sustaining Engineering, Global Supply Chain) and/or Multiple Sites (e.g. Global or StAR projects, Strategic Transfers)
• Proven leadership skills in change management and project management.
• Demonstrates excellent verbal and written communications to project team and all stakeholders at multiple levels.
• Must have proven skills in people management, collaboration, influencing and team building.
• Must be proficient with MS Project or similar Project planning tool.
• A formal Project Management qualification or certification is an advantage.
• Strong communication skills across all levels in organization – tailors the message to the audience

Responsibilities:

• Partnering with senior engineers to lead and support projects for product qualification, change management, process development, cost reduction, capacity management, and all related PDM activity
• Supporting product complaints and NCEP/CAPA investigations of defective components received to identify and address root causes
• Collaborating with cross-functional teams to qualify and improve supplier processes; submit and manage manufacturing change requests as necessary
• Collaborates with suppliers and extended team for investigation of device issues or supply constraints through use of process capability studies, Six Sigma and Value Improvement projects, report preparation and process/test documentation.
• Troubleshooting new and existing product issues related to design, material, or processes; analyze and interpret test results and use standard reports and documentation communicate findings to key stakeholders
• Ensuring corrective actions are identified, implemented and controlled by suppliers

Education & Experience:

• Bachelor's degree in any engineering discipline with a minimum of 3 years engineering experience
• Experience working with suppliers and/or contract manufacturers
• Experience managing technical problems and solution implementation
• Ability to travel up to 25% (domestic and international)
• Experience working in medical device or similarly regulated industry
• Ability to communicate effectively on all levels with strong technical writing and reporting skills
• Organized and detail-oriented; ability to prioritize and manage multiple projects
• Strong interpersonal skills with ability to develop internal and external relationships
• Results-driven with strong critical thinking and analytical skills
• Good understanding of, statistical methods, problem-solving techniques, lean manufacturing and six sigma methodologies
• Understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).

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Job Title:Production Unit Operations Manager, PCT

Reporting to:Production Director

Onsite, Galway

Key Responsibilities:

• Works with the Engineering Manager and Quality Manager to put in place a strategic plan for the Production Unit and through all of the sites key systems, delivers the plan through a collaborative approach with the resources in the Production Unit.
• Leverages Lean initiatives as programs and procedures are implemented within the Operational areas / Value Stream to improve safety, quality and customer indicators, reduce waste, improve processes and labour efficiencies, and reduce direct operating expenses.
• Partners with Finance, Human Resources, Quality and Production Planning to optimise department performance. Champions effective employee engagement, relations and communication within the department.
• Determines appropriate staff levels, schedules, and resources. Establishes cross-functional team relationships. Works cross-functionally in identifying and resolving technical issues.
• Establishes clear accountabilities for direct reports and staffs to motivate and develop through understanding, personal development, and lifelong learning.
• Develops, manages and monitors department budgets.
• Plans and allocates resources to ensure optimisation of customer service targets, inventory levels, procurement delivery and costs.
• Fosters and recognises continuous improvement initiatives within the department at all levels
• Nurtures a risk-taking environment and encourages employees to reach for new milestones.
• Ensures department adherence to regulatory and GMP requirements.
• Promotes quality and customer satisfaction as a way of life in all department activities.
• Intuitively identifies technical risks and acts proactively to reduce negative impact on product and projects. Ensures compliance in all of our practices and procedures.
• Use the tools and resources available to meet customer production needs based upon sales forecast.
• Drives functional excellence initiatives, delivers high quality functional deliverables.
• Possess a broad in-depth knowledge of manufacturing processes and systems and has demonstrated the ability to specify appropriately.
• Works with EHS to identify significant environmental impacts of BSIL operations and to establish goals and targets around significant environmental impacts.

Skills

• Leadership skills. Communication, Relationship building, coaching and developing people
• Operational excellence and lean thinking, with a systems mindset.
• Change management especially in area of culture.
• Organisational awareness and business acumen.
• Strong manufacturing line layout and flow competencies.
• Project management skills.
• Strategic and Critical Thinker
• Supply chain and Capacity Planning competencies.
• Financial Management

Education and Experience

• Bachelor’s degree in Manufacturing/Engineering field. Master’s preferred.
• Minimum Experience: 8/10+ years in an operations environment.
• 5 years+ in leadership capacity.