Manufacturing Engineer

About This Role

Join EyePoint as a Manufacturing Engineer to lead process sustaining and improvement for component, device, and packaging projects, applying continuous improvement methodologies to enhance manufacturing efficiencies.

Responsibilities

• Identify and lead engineering related projects to continuously review and revise processes in production to enhance quality, yield, and efficiency
• Author and execute equipment commissioning and qualification protocols and reports
• Apply lean manufacturing methodologies to reduce costs and increase efficiency
• Oversee production operations and troubleshoot technical issues in cleanroom environments
• Coordinate and communicate engineering related activities with product vendors and suppliers
• Support the design, development, and optimization of processes, including upstream and downstream operations
• Troubleshoot process-related issues and lead quality investigations and implementation of corrective actions
• Create, customize and implement tooling and fixturing to increase efficiency and product quality in manufacturing
• Generate and maintain process documentation, including standard operating procedures, work instructions, and batch records
• Work in cross-functional teams and with other departments to implement changes
• Serve as subject matter expert from functional area
• Ensure compliance with GMP and regulatory standards

Requirements

• Strong mathematical and statistical abilities
• Proficiency with equipment, facility, and process validations
• Analytical skills to analyze process steps and seek optimization
• Mechanical skills to oversee the use of equipment used in production
• Familiarity with engineering software like AutoCAD and SOLIDWORKS
• Proficient in Microsoft Applications (Word, Excel, PowerPoint, Visio)
• Strong commitment to compliance and ethical standards
• Proficiency with cGMP regulations and quality management systems
• Proactive and creative problem solver who is highly organized and detail oriented
• Strong listening and communication skills -both written and verbal
• Exceptional project management skills; proficiency in tracking processes and projects

Qualifications

• Bachelor of Science
• A minimum of 3-5 years of experience in the medical device and/or pharmaceuticals industry

Nice to Have

• Experience in life sciences, medical devices, or regulated industry

Skills

* Required skills

Benefits