About this role
The Manufacturing Engineer I is an entry level position. This position will provide engineering and technical services to internal customers to achieve the overall manufacturing goal of consistently producing quality, low-cost products which meet or exceed customer expectations by addressing major production problems, ensuring optimum manufacturing methods and techniques and implementing cost improvement programs. The Manufacturing Engineer I will support basic engineering assignments, validations of simple equipment, and perform investigations for quality issues. The Manufacturing Engineer I will often play a supporting role on larger projects, taking direction from experienced engineers and the engineering manager.
• Executes basic engineering assignments independently such as ECNs, NPEs, LCNs, etc • Executes validations of basic equipment, may require supervision or oversight from more experienced engineers • Supports experienced engineers perform basic tasks or validations on large scale projects such as product transfers or the integration of new products from R&D • May be required to own specific equipment to perform Preventative Maintenance and Calibration • Partners with the assigned Value Stream Team to ensure performance needs are met or exceeded by ensures enough capacity, minimum scrap variances, and labor efficiency when equipment are involved • Ensures that manufacturing validations, processes, and procedures comply with FDA, OSHA, ISO, and corporate regulations, policies and procedures. • Assists equipment technicians, as required, to troubleshoot equipment malfunctions • Assist experienced engineers in executing improvement programs such as cost, quality, or capacity. • Work with technical operations to modify part designs to improve manufacturability • Maintain a continuous improvement mindset and work with management to obtain buy in for technical improvement programs • Perform other duties as directed by management
• Engineering degree in mechanical, electrical, chemistry, biomedical, microbiology or similar. • Technical or internship experience in manufacturing environment that is both labor and machine intensive is preferred. • Basic knowledge project management. • In-depth understanding of equipment, equipment qualification and process validation. • Experience with lab and chemistry equipment such as weighing scales, mixing processes and steam sterilizers is an advantage. • Creative individual who is able to communicate and coordinate good ideas through to implementation. Ability to communicate well, both orally and written. • Six Sigma Yellow Belt (Green Belt desired) & solid understanding of Lean Principles. • Familiarity with programs such as Excel, SolidWorks, MiniTab, Microsoft Word, Power Point, etc. • Thorough understanding of medical device manufacturing, especially as it relates to FDA (GMP) manufacturing requirements. • Fluent in Spanish. Ability to communicate well in English, both orally and written. • Passing of background check which may include verification of prior employment and educational records.