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 objectives
• to Lean Manufacturing initiatives by assisting in defining requirements
• processes and procedures to enhance quality and reduce costs for projects
• comprehensive and understandable technical documentation, including written technical descriptions of processes and procedures
• engineering in Material Review Board deliberations concerning material dispositions
• in cross-functional teams as assigned
• compliance with procedures and regulations, including maintaining regulatory requirements
• safety and adhere to safety protocols, attend safety training, and wear PPE as required
• project plans to meet timelines and prepare Engineering Change Orders for processes and components

Requirements:

• in engineering/manufacturing for medical devices
• of FDA regulations and cGMP principles (ISO 9001, ISO 13485)
• with Silicone molding preferred
• in Pro-E / CREO and/or SolidWorks desirable
• proficiency in Microsoft software
• to interpret technical drawings and specifications
• in English, both written and verbal
• reading, writing, communication, and organizational skills

Pay Range:

$25-33/hr