Manufacturing Engineer II

CooperCompanies•Trumbull, CT

About The Position

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.

Requirements

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.

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.