Job Description

The Sr. Manufacturing Engineer is an experienced engineering position with 1-2 reports. 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 Sr. Manufacturing Engineer will support large, complex engineering assignments, validations of equipment, and perform investigations for quality issues. The Manufacturing Engineer III will manage large scale projects and will often manage a cross-functional project team.

• Executes basic engineering assignments independently such as ECNs, NPEs, LCNs, etc
• Executes product transfers and acquisitions, managing the project throughout the PTR/PAR process
• Executes product integrations from R&D
• Executes validations of complex equipment and manufacturing lines
• Owns specific equipment to perform Preventative Maintenance and Calibrations and is responsible for investigations of EIRs/MIRs
• Partners with the assigned Value Stream Team to ensure performance needs are met or exceeded by ensure 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
• Define and execute 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.
• 5–10 years of technical in manufacturing environment that is both labor and machine intensive
• In-depth knowledge of project management, PMP preferred
• 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 Green Belt (Black belt preferred) & 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.