Job Description:

This role involves providing essential tools and support to engineering and production teams while ensuring alignment with company quality and cost standards. Responsibilities include developing and implementing processes, procedures, equipment, fixtures, and training programs, all adhering to sound engineering principles and compliance with Good Manufacturing Processes (GMP) and ISO standards. Additionally, the position supports fellow engineers and various departments as necessary, operating at an advanced level.Responsibilities:Continuous Improvement initiatives by identifying, executing, and promoting objectivesto Lean Manufacturing initiatives by assisting in defining requirementsprocesses and procedures to enhance quality and reduce costs for projectscomprehensive and understandable technical documentation, including written technical descriptions of processes and proceduresengineering in Material Review Board deliberations concerning material dispositionsin cross-functional teams as assignedcompliance with procedures and regulations, including maintaining regulatory requirementssafety and adhere to safety protocols, attend safety training, and wear PPE as requiredproject plans to meet timelines and prepare Engineering Change Orders for processes and componentsRequirements: in engineeringmanufacturing for medical devicesof FDA regulations and cGMP principles (ISO 9001, ISO 13485)with Silicone molding preferredin Pro-E CREO andor SolidWorks desirableproficiency in Microsoft softwareto interpret technical drawings and specificationsin English, both written and verbalreading, writing, communication, and organizational skillsPay Range:$25-33hr