This role will report to the Director for Digital Manufacturing.
Manufacturing Engineer
- Develop and optimize manufacturing processes for our sleep apnea treatment devices, ensuring efficiency, quality, and compliance with regulatory standards (FDA, EU MDR, ISO13485).
- Collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Supply Chain, to ensure seamless product transfers and successful new product introductions.
- Document manufacturing processes, procedures, and changes, ensuring comprehensive and accurate documentation write-ups.
- Identify and implement process improvements to increase manufacturing efficiency, reduce costs, and enhance product quality.
- Conduct root cause analysis and implement corrective and preventive actions (CAPAs) to address manufacturing issues and ensure compliance with regulatory requirements.
- Drive continuous improvement initiatives, employing Lean Six Sigma principles and methodologies to streamline processes and optimize resource utilization.
- Participate in validation activities, including process validation, equipment qualification, and IQ/OQ/PQ activities, ensuring compliance with applicable regulations.
- Support risk management activities, including the identification and mitigation of manufacturing risks.
Production Support
- Collaborate with production supervisors to ensure smooth operations and adherence to production schedules and targets.
- Provide technical expertise and guidance to production supervisors and operators on manufacturing processes, equipment operation, and quality standards.
- Document production processes, standard operating procedures (SOPs), and best practices, ensuring accurate and up-to-date documentation write-ups.
- Assist in the training and development of production personnel, ensuring they are equipped with the necessary skills and knowledge to perform their roles effectively.
- Monitor production metrics, such as yield, cycle time, and productivity, and identify areas for improvement.
- Work closely with the Quality Assurance team to implement and maintain robust quality control measures, including inspection procedures, non-conformance handling, and CAPA execution.
- Participate in root cause analysis and problem-solving activities to address production issues and minimize downtime.
- Collaborate with the Engineering team to implement process improvements, equipment upgrades, and new technologies to enhance productivity and product quality.
- Ensure compliance with safety regulations and promote a culture of safety within the production area.
- Assist in the implementation and maintenance of visual management tools, such as standard work instructions, workstations layouts, and production performance boards.
- Support production supervisors in conducting performance evaluations and providing constructive feedback to team members.
Experience and Education
- Bachelor's degree in Engineering or a related field. Advanced degree is a plus.
- Minimum of 8 years of experience in manufacturing engineering within the medical device industry, with a focus on FDA regulated and ISO13485 certified products.
- Knowledge and understanding of FDA regulations, EU MDR requirements, and ISO13485 quality management system.
- Proven track record in developing and optimizing manufacturing.
- Experience with connected devices and wireless technologies is highly desirable.
- Proficiency in statistical analysis and the application of Lean Six Sigma methodologies for process improvement.
- Excellent problem-solving skills with the ability to conduct root cause analysis and implement effective corrective actions.
- Familiarity with risk management practices and tools (e.g., FMEA).
- Strong project management skills with the ability to prioritize and manage multiple projects simultaneously.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across different teams and levels of the organization.
