Job Summary
Seeking a seasoned Operations Engineer to spearhead the optimization of manufacturing processes for neuro medical devices.
This role requires a collaborative individual with expertise in process design, implementation, and continuous improvement. The successful candidate will work closely with cross-functional teams to drive efficient production, ensure quality, and exceed customer expectations.
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Key Responsibilities
* Lead the development and execution of robust manufacturing processes for our flagship device, encompassing product assembly, testing, and packaging.
* Provide technical support to the manufacturing line, ensuring seamless day-to-day operations and swift resolution of issues.
* Monitor line performance, efficiency, and output, utilizing data-driven insights to inform improvements.
* Evaluate 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.
* Develop, 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 resilient manufacturing operations.
* Drive 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.
* Maintain detailed process documentation, including work instructions, inspection procedures, and batch records, to ensure clarity, traceability, and compliance.
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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