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Boston Scientific Senior Manufacturing Engineer Ireland 384075386
Yesterday
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Job Purpose:
The Senior Engineer will take ownership of advanced automated manufacturing equipment and processes, including robotics, machine vision, servo motion control, pneumatics, and PLC-based automation. You will ensure equipment reliability, process stability, and regulatory compliance while leading automation, validation, and continuous improvement initiatives.
Key Responsibilities
• Lead engineering initiatives with a strong focus on the full equipment and systems validation lifecycle (IQ/OQ/PQ), across packaging, sterilisation, and shipping processes ensuring alignment with internal procedures and regulatory standards .
• Evaluate, select, and implement new equipment, technologies, and processes through rigorous research, analysis, and application of engineering best practices.
• Manage backend operations—including packaging, sterilisation, and shipping—to meet production targets and maintain seamless supply chain performance.
• Drive automation and digitalisation projects to enhance operational efficiency, reliability, and compliance.
• Support product and process validation activities, including documentation development and execution of qualification protocols.
• Collaborate on new product introductions and technology transfers, ensuring smooth integration into existing manufacturing systems.
• Identify and lead process improvement initiatives using Lean, Six Sigma, or equivalent methodologies to reduce waste and optimise performance.
• Review and contribute to technical documentation, change controls, reports, and memos to support continuous improvement and knowledge transfer.
• Provide hands-on technical leadership and mentorship to junior engineers and technicians, fostering a culture of learning and accountability.
• Ensure full compliance with GMP, FDA, BSI, EEO regulations and internal quality systems, supporting audits and inspections as required.
• Actively participate in cross-functional teams, working closely with Quality, Regulatory Affairs, Operations, and Supply Chain to deliver business-critical outcomes.
Education & Experience:
• Honours Bachelor’s degree in Mechanical, Manufacturing, or Biomedical Engineering.
• Minimum 5 years’ experience in a regulated manufacturing environment (MedTech or pharma).
• Proven experience in at least two or more of the following: Packaging, Sterilisation, Shipping, Automation, Validation, Process Improvement, Product Launches.
• Strong understanding of GMP, validation protocols, and risk management.
• Hands-on experience with equipment troubleshooting, process optimisation, and documentation.
• Familiarity with technical writing, including protocols, reports, and SOPs.
Key Competencies
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal abilities.
• Collaborative mindset with a commitment to mentoring and team development.
• Detail-oriented with a proactive approach to continuous improvement.
• Ability to manage multiple priorities in a fast-paced, regulated environment.
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