Position Overview
The successful candidate will play a key role in overseeing and optimizing the manufacturing processes for medical devices. This individual will collaborate closely with cross-functional teams to ensure the efficient production of high-quality products that meet regulatory standards and exceed customer expectations.

Key Responsibilities

• Lead the design, implementation, and optimization of manufacturing processes for the pivotal device, including but not limited to product assembly, testing, and packaging.
• Provide technical support to the manufacturing line.
• Proactive monitoring of line efficiency, performance and output
• Ensure manufacturing activities are managed in accordance with the company's quality system and policies, including diligent recording of results and writing reports.
• Identify and implement opportunities for improved efficiency.
• Establish new manufacturing processes and fixtures to facilitate the introduction of new product lines.
• Define and complete process validation activities as required in accordance with the Quality System.
• 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 team to ensure compliance with regulatory requirements and industry standards.
• Develop and maintain detailed process documentation, including manufacturing and inspection procedures , work instructions, and manufacturing batch records.
• Maintain traceability of all finished good products
• Manage equipment specification, procurement, calibration, and maintenance.
• Represent the company externally, for example at physician line tours.
• Liaise with component and service suppliers on delivery schedule and any quality problems.

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, preferably with neuro interventional devices.
• Strong understanding of basic engineering principles.
• Strong understanding of design control principles and regulations, including FDA QSR (21 CFR 820) and ISO 13485

Job Specification - Senior Operations Engineer

• Experience with risk management methodologies, such as ISO 14971, and application to medical device development.
• • Proficiency in process validation techniques, including protocol development, execution, and documentation.
• • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• • Detail-oriented with strong analytical and problem-solving abilities.
• • Ability to work independently and manage multiple tasks simultaneously in a fast-paced, dynamic environment.
• • Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience

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