Designs and develops manufacturing processes for medical devices, including process development, design for manufacturing, fixture/tool and equipment design, documentation, implementation, problem solving, training, transfer to manufacturing, and hands-on manufacturing assistance.
Working cross-functionally with our customer’s design team and our internal team, the Manufacturing Process Engineer will bring products from design and prototyping through testing, design verification/validation, manufacturing, and post introduction monitoring.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Develop new and improve existing manufacturing processes to produce high-quality medical devices. Use technical knowledge and industry experience to ensure manufacturing processes are capable and “designed for manufacture.”
Plan, conduct and analyze process/product tests to understand variables and interactions. Write engineering reports to document tests, results and conclusions.
Specify equipment and processes to meet customer requirements/specifications. Design and implement new or improved fixtures and tools to support manufacturing processes.
Develop clear process and manufacturing documentation. Train production and set-up personnel.
Maintain relationships with tool vendors and suppliers. Ensure clear communication of specifications and deliverables. Specify and order materials for process development and prototype manufacturing.
Utilize six-sigma quality tools, when appropriate, to define, measure, analyze, improve and control processes and outcomes.
With Quality Engineering, participate in protocol development and execution of equipment IQ and process validations (OQ/PQ) per applicable internal and external procedures/standards.
Lead projects as requested pertaining to process development, fixture development, and/or equipment implementation.
Maintain communication with manufacturing on established products concerning changes, revisions, problems and take necessary action.
Establish and maintain open communications and productive relationships with individuals in all levels of the organization, customers and suppliers. Provide status updates and ongoing communications to suppliers, internal colleagues and customers.
Enforce and contribute to a culture of safety and GMP compliance through technical specifications, training and awareness of standards and regulations. Comply with FDA, ISO and internal QSR requirements