Manufacturing Engineer

Manufacturing Engineer

The Manufacturing Engineer is responsible for the design, development, and improvement of manufacturing processes and equipment in a medical device manufacturing environment. This is a hands-on position which will provide key technical support to the Jaffrey site. This person will have a leadership role in engineering functions such as specifying and validating new equipment and materials, troubleshooting processes, managing projects, and identifying and implementing process/product improvements.

The engineer will work within a cross-functional value stream team to monitor and improve yields, resolve material issues, customer complaints and to review potential new business.

Principal Responsibilities:

• Identify opportunities and implement changes to reduce variation and improve scrap rates and productivity
• Develops manufacturing processes by designing and modifying equipment for fabricating, building, assembling, and installing components
• Provide support to R&D, manufacturing, marketing, customer service, and interface with customers and suppliers
• Using six sigma principles, identify key process parameters and develop monitoring tools to enable cost reduction efforts
• Manage projects in a matrix organization as a team leader, whose duty encompasses the full scope of the project
• Conduct validations independently and assist technicians and engineers in executing validation protocols (IQ/OQ/PQ/TMV)
• Drive capability improvements in manufacturing areas
• Mentor and coach less experienced engineers and technicians in developing new products and technologies
• Assist and support OEM Strategic Initiatives (product line transfers)
• Assist with the design of gauges, fixtures, tooling and methods
• Conduct design and process FEMA's
• Implement cost reduction or cost avoidance by working closely with the Value Stream Team

Education / Experience Requirements:

• Bachelor's degree in engineering required o Bachelor's in Plastics, Chemical, Biomedical, or Mechanical preferred
• 3+ years of experience in process development/improvement in a manufacturing environment. o Experience in Medical Device or regulated environment (ISO, FDA, etc.) preferred

Specialized Skills / Other Requirements:

• Basic understanding of extrusion tooling and processes, preferred.
• Good working knowledge of manufacturing methods, and an ability to effectively persuade people of all different levels within the organization
• Knowledge of precision extrusion, machining methods, tooling, and molding experience writing and performing qualifications of equipment, product, and processes
• Experience with lean six-sigma manufacturing and preferably, green-belt certified
• Proficient in Solidworks and/or comparable CAD software
• Excellent oral and written communication skills
• Ability to prioritize and work independently
• Product transfer experience preferred.
• Familiar with design controls, FDA regulation, and GMP practices