Operations Engineer Role
We are seeking a highly skilled Operations Engineer to join our team at Life Science Recruitment Ltd. The ideal candidate will have experience in overseeing and optimizing manufacturing processes for neuro medical devices.
Main Responsibilities:
* Design, implement, and continuously improve manufacturing processes for our flagship device, including product assembly, testing, and packaging.
* Provide hands-on technical support to the manufacturing line, ensuring smooth day-to-day operations and swift resolution of issues.
* Monitor line performance, efficiency, and output, using data-driven insights to drive improvements.
* E nsure all manufacturing activities are conducted in compliance with our Quality Management System (QMS) and applicable policies, including accurate documentation and comprehensive reporting.
* Identify and implement efficiency enhancements to streamline manufacturing workflows and reduce waste.
* Support the introduction of new product lines by establishing robust manufacturing processes, tooling, and fixtures.
* Plan, execute, and document process validation activities in alignment with regulatory and quality system requirements.
* Participate in process risk assessments and contribute to mitigation strategies to ensure robust manufacturing operations.
* Lead and support continuous improvement initiatives focused on optimizing product yield, reducing cycle time, and maximizing resource utilization.
* Collaborate cross-functionally with R&D, Quality Assurance, and Regulatory Affairs to ensure compliance with industry regulations and internal standards.
* Develop, review, and maintain detailed process documentation including work instructions, inspection procedures, and batch records to ensure clarity, traceability, and compliance.
* Maintain full traceability of finished goods in accordance with regulatory and internal requirements.
* Manage equipment lifecycle activities, including specification, procurement, installation calibration, and preventive maintenance.
* Represent the company during external engagements such as physician line tours, showcasing manufacturing capabilities and quality practices.
* Coordinate with suppliers regarding delivery schedules, quality concerns, and continuous improvement opportunities.
Requirements:
* Bachelor's degree in engineering or a related technical field.
* Minimum of 3 years of experience in Operations engineering within the medical device industry, preferably with neuro interventional devices.
* Strong understanding of basic engineering principles.
What We Offer:
* Competitive salary
* Share options
* Excellent opportunity to develop your experience and career in an exciting start-up helping develop a product from its very early stages.