Job Description

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.