Senior Operations Engineer sought to oversee and optimize manufacturing processes for neuro medical devices in a dynamic start-up company focused on novel devices for Intracranial Atherosclerotic Disease treatment.
As a Senior Operations Engineer, you will play a key role in ensuring the efficient production of high-quality products that meet regulatory standards and exceed customer expectations.
Key responsibilities include:
- Leading the design, implementation, and optimization of manufacturing processes for pivotal devices.
- Providing technical support to the manufacturing line.
- Monitoring line efficiency, performance, and output.
- Ensuring manufacturing activities are managed in accordance with the company's quality system and policies.
- Identifying and implementing opportunities for improved efficiency.
- Establishing new manufacturing processes and fixtures to facilitate the introduction of new product lines.
- Defining and completing process validation activities as required in accordance with the Quality System.
- Participating in risk assessments and mitigation activities related to manufacturing processes.
- Driving continuous improvement initiatives to optimize production yield, cycle time, and resource utilization.
- Collaborating with R&D, Quality Assurance, and Regulatory Affairs teams to ensure compliance with regulatory requirements and industry standards.
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.