דרושים Manufacturing Manager ב-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

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.