Manufacturing Engineer I

About the Role

The Manufacturing Engineer I is responsible for optimizing manufacturing processes and ensuring the production of high-quality medical devices. This role primarily contributes to sustaining activities and continuous improvement initiatives that reduce costs and increase the quality of CooperSurgical’s manufacturing processes. Strong partnerships with production, quality, product engineering, and regulatory departments are expected.

The Manufacturing Engineer I drives manufacturing excellence and optimizes production processes for medical device and fertility products, focusing on lean principles, process efficiency, and a culture of continuous improvement.

Responsibilities

• Execute sustaining manufacturing activities, including change orders for existing products and processes, investigating non-conformances, and supporting maintenance and calibration technicians.
• Design and develop efficient manufacturing processes for medical device products, emphasizing quality, cost-effectiveness, and scalability.
• Optimize existing manufacturing processes to improve efficiency, yield, and productivity while maintaining compliance with regulatory and quality standards, often using lean manufacturing techniques.
• Conduct process validations, process capability studies, and root cause analyses to identify and resolve manufacturing issues, implementing corrective actions as needed.
• Assist in developing project plans and proposals, including 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.
• Foster a culture of knowledge sharing and professional development.
• Develop and maintain manufacturing documentation, such as work instructions, standard operating procedures, and process control plans, ensuring compliance with regulatory requirements.
• Support the manufacturing floor by partnering with maintenance engineers and technicians to resolve day-to-day downtime.
• Travel may be required to attend meetings or visit manufacturing sites (approximately 10-20% travel expected).

Requirements

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a related field.
• 0-5 years of experience in manufacturing engineering within the medical device or pharmaceutical industry.
• Introductory knowledge of medical device manufacturing processes.
• Strong computer skills, including proficiency in Excel, Word, PowerPoint, and Visio (advanced skills preferred).
• Awareness of Lean Six Sigma concepts, 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.
• Introductory knowledge of quality and regulatory requirements, such as ISO 13485, FDA QSR, EU MDR, and GMP.
• Proficient project management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
• Excellent verbal and written communication skills, with the ability to convey complex technical information to diverse audiences.

Work Environment

• Occasional lifting of up to 35 kilograms may be required.
• Prolonged sitting in front of a computer is common.
• Ability to work in uncomfortable positions when required (e.g., repairing manufacturing equipment).