Manufacturing Engineer Role
We are seeking an experienced manufacturing professional to lead the introduction of new equipment and processes to improve cost efficiency and increase production volumes.
Main Responsibilities:
* Collaborate with cross-functional teams and external manufacturers to develop and implement new manufacturing processes, ensuring quality, productivity, and cost-effectiveness.
* Optimize existing manufacturing processes to improve efficiency, reduce costs, and enhance product quality.
* Design, develop, and implement manufacturing processes, including equipment selection, layout, and validation activities, to ensure compliance with regulatory requirements.
* Conduct risk assessments and implement corrective and preventive actions to mitigate potential issues.
* Lead process validation activities, including IQ, OQ, and PQ protocols, to ensure smooth transitions from R&D to manufacturing.
* Develop and document manufacturing procedures, work instructions, and quality standards to ensure compliance with regulatory requirements.
* Provide technical support and troubleshooting expertise to resolve manufacturing issues, ensuring minimal downtime and maximum productivity.
* Collaborate with suppliers to ensure the availability of high-quality components and materials, while evaluating and selecting materials, components, and equipment for optimal cost-effectiveness and performance.
* Implement and manage process controls, including statistical process control (SPC) techniques, test method validation, and process validation activities, to ensure consistency and reliability.
* Identify and implement automation and technology advancements to improve efficiency, productivity, and quality in manufacturing operations.
* Ensure compliance with relevant regulatory standards, such as FDA regulations and ISO requirements, to maintain a safe and healthy work environment.
Requirements:
* Bachelor's or Master's degree in Engineering or a related field.
* Solid experience in medical device manufacturing, operations, and engineering, with a strong understanding of manufacturing processes and quality management systems.
* Strong knowledge of manufacturing processes, including assembly, testing, and packaging, with proficiency in process validation, risk management, and statistical analysis techniques.
* Excellent problem-solving skills and the ability to analyze complex manufacturing issues, with strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
* Detail-oriented with a commitment to maintaining high standards of quality and compliance, with experience working in a fast-paced manufacturing environment.
* Familiarity with Lean Six Sigma methodologies and design for manufacturability (DFM) principles is a plus.