Manufacturing Engineer – Medical Devices

We are searching for a Manufacturing Engineer for a rapidly growing medical devices company. This exciting company, in the cardiovascular space, is expected to go public next year. It has several diagnostic platforms in development.

The Manufacturing Engineer will work to design, develop, and implement, new and improved manufacturing processes for the company’s control console program. The Manufacturing Engineer will provide daily support of products, processes, materials and supplier management, and equipment for new and sustaining products.

Requirements for the Manufacturing Engineer:

• Bachelor’s Degree in engineering preferably mechanical or biomedical.
• 3+ years’ medical device experience in process/manufacturing engineering role.
• Experience in Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer experience, product/process failure mode and effects analysis (FMEA), and problem solving methodologies.
• Experience with validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ)
• Understanding of medical device design controls / quality systems and product development processes
• Experience in a regulated environment; preferably medical device
• Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines and policy statements.
• Excellent verbal/written communication skills
• Ability to organize, records, and implement procedures
• Six Sigma training, certification preferred
• Experienced in CAD, preferably SolidWorks

Responsibilities of the Manufacturing Engineer:

• Develop and implement new manufacturing processes for both new and existing disposable medical devices.
• Collaborate with global suppliers to understand and define their manufacturing processes, equipment, and tools/fixtures to ensure quality standards are met.
• Conduct characterization studies, design experiments (DoE), and author/execute validation and verification protocols for manufacturing processes and inspection methods (IQ, OQ, PQ).
• Prepare manufacturing documentation, including work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents.
• Lead teams of engineers and technicians in manufacturing-related activities.
• Innovate and develop processes, procedures, tooling, and automation solutions.
• Train and provide guidance to team members and manufacturing personnel.
• Drive initiatives for product and process improvements and technical excellence.
• Manage department budgets, schedules, and resource allocation.

Occupational Category: 17-2141 Mechanical Engineers