Work as part of a cross-functional team in successful launches of medical devices and electromechanical equipment.
Manage and execute multiple projects simultaneously, overseeing program timelines and ensuring compliance with FDA, ISO, and quality standards, resulting in a track record of on-time deliveries of quality products.
Own continuous improvement initiatives, including design of tooling, providing design for manufacturing feedback, and maintaining technical documents such as drawings, runlists, bill of materials, and work instructions.
Conduct root cause analysis investigations to identify and resolve production issues, applying results to risk analysis to ensure product safety and improve overall quality.
Required
BS in Mechanical, Manufacturing or related technical degree with 2-5 years of manufacturing engineering experience -preferably in an ISO 9001 or ISO 13485 environment
Experience with Contract Manufacturers or OEM’s
Experience with for a 3D printing company is helpful
