We're seeking a Senior Operations Engineer to join our dynamic team, playing a crucial role in enhancing our manufacturing procedures for medical devices. The ideal candidate will lead the design, implementation, and optimization of manufacturing processes, ensuring compliance with regulations and exceeding customer expectations.

Key Responsibilities:

• Lead the design, implementation, and optimization of manufacturing processes, including product assembly, testing, and packaging.
• Provide technical support to the manufacturing line, ensuring smooth operations.
• Proactively monitor line efficiency, performance, and output, identifying opportunities for improvement.
• Ensure manufacturing activities adhere to the company’s quality system and policies, including meticulous recording of results and report writing.
• Establish new manufacturing processes and fixtures to support the introduction of new product lines.
• Conduct process validation activities in accordance with the Quality System requirements.
• Participate in risk assessments and mitigation activities related to manufacturing processes.
• Drive continuous improvement initiatives to optimize production yield, cycle time, and resource utilization.
• Collaborate with R&D, Quality Assurance, and Regulatory Affairs teams to ensure compliance with regulatory requirements and industry standards.
• Develop and maintain detailed process documentation, including manufacturing procedures, work instructions, and batch records.
• Manage equipment specification, procurement, calibration, and maintenance.
• Represent the company externally, such as during physician line tours.
• Liaise with component and service suppliers regarding delivery schedules and any quality issues.

Requirements:

• Bachelor's degree in engineering or a related technical field.
• Minimum of 5 years of experience in Operations engineering within the medical device industry.
• Strong understanding of basic engineering principles.
• Familiarity with design control principles and regulations, including FDA QSR (21 CFR 820) and ISO 13485.

For more information on this role in please contact Johanne Kennedy on +353 86 440 3725 / choices@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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