Manufacturing Engineer

The manufacturing engineer will work to drive manufacturing engineering projects to reduce costs, improve productivity and product quality of existing products and processes, with a strong emphasis on Lean manufacturing. This role will support the design and development of processes, equipment, and documentation to successfully implement new products into manufacturing. The manufacturing engineer must be able to manage cross-functional teams and communicate project progress to management effectively.

The manufacturing engineer will provide technical expertise and manufacturing support for the evaluation of proposed medical device designs for manufacturability and will be responsible for developing and implementing process validation protocols and reports (IQ/OQ/PQ). This role will develop, implement, train, and monitor the effectiveness of engineering systems and procedures to ensure compliance with 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 customer's expectations while meeting process metrics. The manufacturing engineer complies with policies, regulations and values for safety, quality, environmental and financial standards.

Essential Duties and Responsibilities:

· Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling.

· Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.

· Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.

· Adapts machine or equipment design to factory and production conditions.

· May incorporate inspection and test requirements into the production plan.

· Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

· Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.

· Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

· Leads manufacturing engineering project plans by utilizing project management skillsets that include creating timelines, managing budgets, and understanding resource allocations.

· 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.

· 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 management.

· Drives manufacturing performance to meet schedules that allow for superior customer satisfaction and high plant efficiency by establishing and executing operating plans and objectives.

· Coordinate equipment maintenance and repair services and ensure 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.

· Develop and coordinate execution of protocols for equipment and process validations, prepare final reports following the execution.

· Responsible for evaluation and analysis of data, lead investigation and documentation of all validation deviations and determine impact on the validations.

· Assist in the implementation and maintenance of the Facility Validation Master Plan.

· Design and develop test strategy and methodology for the validation of the products, processes, and equipment.

· Participant in equipment development, provide support of user requirement specification (URS) creation, factory acceptance test (FAT) and site acceptance test (SAT) activities.

· Provide support for pFMEA (process failure mode effect analysis), CAPA (corrective action and preventive action), and NC’s (non-conformances) efforts as assigned. Initiates investigations of problems and deficiencies to ensure a high level of product quality.

· Prepare and maintain manufacturing work instructions and provide training as required.

· Act as a subject matter expert or a project lead for manufacturing engineering projects.

· Performs other manufacturing duties as required.

Required Job Qualifications:

· Bachelor’s Degree or higher in material science, biomedical engineering, mechanical engineering, industrial engineering or other engineering discipline.

· Minimum of 4 years of relevant experience.

· Minimum of one to two years related experience in an FDA/GMP regulated industry.

· Experience with and effective application of design, validation protocol and report creation, statistical process control (SPC), design of experiments (DOE), process control plans, sampling methodologies, data nalysis.

· Experience with design, review, execution, and approval of Installation, operation and performance qualification protocols, and reports (IQ/OQ/PQ).

· Experience with statistical process control (SPC), design of experiments (DOE), process control plans, sampling methodologies, data analysis and problem-solving techniques.

· Experience with measuring devices, electromechanical machinery, and troubleshooting.

· Proficient in SolidWorks, Minitab, Word, Excel, and Project.

· Experience developing work instructions and training.

Preferred Job Qualifications:

· Experience in automation programming and troubleshooting.

· Six Sigma or Lean Six Sigma green/yellow belt.

· Extensive knowledge of the ISO/FDA requirements for medical devices.

· Experience and competence 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.

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

· 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.