Description

Job Title:  Senior Manufacturing Engineer

Reports to:  Director, Manufacturing Engineering

Department: Manufacturing Engineering

Date: February 21, 2023

General Statement of Duties: 

The Sr. Manufacturing Engineer will work to drive manufacturing engineering projects to reduce cost and improve productivity and product quality of existing products and processes with a strong emphasis on Lean Manufacturing. This engineer will support the design and development of processes, equipment, and documentation to implement new products into manufacturing successfully and must be able to mentor Junior manufacturing engineers for the same. 

The Sr. Manufacturing Engineer is responsible for providing manufacturing engineering services to support efficient manufacturing processes. Engineering services may include process development, project management, process validation, tool design, and trouble shooting. This role will develop, implement, train, and monitor the effectiveness of engineering systems and procedures to ensure compliance to FDA, cGMP, and all other applicable agency regulations.

This requires overall coordination of production, scheduling, health and safety, quality assurance, coaching and development, and continuous improvement activities within the production areas. Responsible for leading the plant in its mission to meet or exceed all our customers’ expectations while meeting process metrics. The Sr. Manufacturing Engineer complies with policies, regulations and values for safety, quality, environmental and financial standards.

Essential Duties and Responsibilities:

• Evaluate quality control processes and make recommendations for improvements in production area.
• Analyze production processes, schedules, methods, and other data and then provide management with reports containing the data and statistics to enable management to better understand future requirements needed for the manufacturing process.
• Analyze and plan workflow, equipment placement and space requirements to improve manufacturing efficiency.
• Assures compliance with all regulations and good manufacturing practices.
• Troubleshoots any production problems; assures that machinery, equipment, and facilities are properly maintained for efficient production; reports any process or equipment problems to manufacturing engineering department leader.
• Drives manufacturing performance to meet schedules that allow for superior customer satisfaction and high plant efficiency by establishing and executing operating plans and objectives.
• Create, maintain, and improve controlled technical documents such as prints, manufacturing specification, bill of materials and routers.
• Coordinate equipment maintenance and repair services and make sure that manufacturer's procedures and instructions are followed to keep production equipment operational.
• Utilize Lean Manufacturing principles to increase productivity / throughput, reduce cost, and /or eliminate waste.
• Prepare and maintain manufacturing work instructions and provide training as required.
• Lead and prioritize multiple medium complexity project assignments and complete work in a timely manner and act as a subject matter expert or a project lead for manufacturing engineering projects.
• Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.
• Lead and execute validation processes DOE, IQ, OQ, and PQ on existing and new capital equipment. 
• Support and/or lead the equipment acquisition process and work with vendors on Design Review, FAT, SAT. 
• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling. 
• Design arrangement of machines within plant facilities to ensure the most efficient and productive layout. 
• Design sequence of operations and specify procedures for the fabrication of tools and equipment and other functions that affect product performance. 
• Adapt machine or equipment design to factory and production conditions. 
• May incorporate inspection and test requirements into the production plan. 
• Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigate and initiate corrective action of problems and deficiencies to ensure product quality. 
• Develop manufacturing processes that are applicable to statistical process control and may develop those techniques. 
• Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. 
• Key participant in DFMEA, PFMEA, Machine Risk Assessments, and CTQ processes assuring specifications are well defined and documented. 
• Assures compliance with all regulations and good manufacturing practices.
• Performs other duties as required.

Requirements

Required Job Qualifications:

• Bachelor’s Degree or higher in material science, biomedical, mechanical, or industrial engineering.
• Proficient in Minitab, Word, Excel, and Project.
• Minimum of ten to twelve (10-12) years of related experience in an FDA/GMP regulated industry.
• Experience in applying statistical techniques such as statistical process control, design of experiments, and problem-solving techniques is required.
• Experience with design, review, execution, and approval of Installation, Operation Performance Qualification Protocols and Reports (IQ/OQ/PQ).
• Experience with equipment commissioning and decommissioning.
• Experience with electromechanical machinery (automation) and troubleshooting.
• Experience with measuring devices (e.g.: calipers, micrometer, pin gauges, optical comparator, etc.).
• Experience with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions.
• Six Sigma or Lean Six Sigma green/yellow belt.

Preferred Job Qualifications:

• Has developed and trained cGMP/GDP to FDA-oversight companies.
• Experience in automation programming and troubleshooting. 
• Extensive knowledge of the ISO/FDA requirements for medical devices.
• Master’s degree in an Engineering or Science discipline or equivalent work experience.
• Experience and competency in reading and understanding drawings, specifications, and performance requirements. 
• Additional class work in management courses, medical device engineering and problem-solving techniques.

Physical Demands:

· Performs primarily office activities in a lighted and ventilated area. May be subject to changes in temperature and exposure to dust.

· Must possess sight/hearing senses or use prosthetics that will enable these senses to function adequately so that the requirements of this position can be fully met. 

· Physical activity includes walking, standing, bending, squatting, reaching above shoulders and lifting up to 40lbs. 

· Must be able to drive an automobile for short and long distances.

· Use good judgement and follow procedures.

· Work under stress in a fast-paced environment.