Manufacturing Engineer II

Job Description

The Manufacturing Engineer II – Industrial (LSS) is responsible for optimizing industrial processes and ensuring the production of high-quality medical devices through implementation of Lean Six Sigma processes and concepts. The Manufacturing Engineer II – Industrial (LSS) will directly contribute to process improvement initiatives and integration projects that reduce costs and increase the quality of CooperSurgical’s industrial processes. Manufacturing Engineer II – Industrial (LSS) is expected to have strong partnerships with the production, quality, product engineering, and regulatory departments.

Responsibilities

• Develop and implement Lean Six Sigma concepts, procedures, and standards at the manufacturing site
• Serve as a manufacturing transfer core-team member on integrations and new product acquisitions, focused on facilitation and implementation of Lean Six Sigma concepts
• Design and development of efficient industrial processes for medical device products, with a focus on quality, cost reduction and quality improvement, and scalability.
• Optimize existing industrial processes to improve efficiency, yield, and productivity while maintaining compliance with regulatory and quality standards, often using Lean Six Sigma methodologies.
• Conduct process evaluations and validations, process capability studies, and root cause and statistical analyses to identify and resolve manufacturing issues, implementing corrective and preventive actions as needed.
• Assist in the development of project plans and proposals that include elements such as Gantt charts, cost-benefit analysis, risk assessments, and regulatory strategies.
• Collaborate with R&D teams to ensure new products are designed for manufacturability, considering assembly methods, equipment selection, and process validation requirements.
• Contribute to the fostering of a culture of knowledge sharing and professional development.
• Develop and maintain manufacturing documentation, including work instructions, standard operating procedures, and process control plans, ensuring compliance with regulatory requirements.
• Support the manufacturing floor via partnering with maintenance engineers and technicians to resolve day-to-day downtime.
  
  
  

Qualifications

• Bachelor’s degree in industrial engineering, Manufacturing Engineering, or a related field.
• Intermediate knowledge of medical device industrial processes
• Strong computer skills with the ability to use Excel, Word, PowerPoint, and Visio. Advanced skills preferred .
• Subject Matter Expertise in Lean Six Sigma concepts and tools for process optimization, statistical analysis tools (e.g., Minitab), and root cause analysis.
• Excellent problem-solving skills and the ability to work effectively in a cross-functional team environment.
• Knowledge of quality and regulatory requirements, such as ISO 13485, FDA QSR, EU MDR and GMP.
• Strong project management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
• Excellent communication skills, both verbal and written, with the ability to convey complex technical information to diverse audiences.