Job Summary:
Under the supervision of the Manufacturing Engineering Manager, the Manufacturing Engineer is responsible for supporting manufacturing by managing & executing assigned projects. This individual will serve as the technical lead on projects and will plan, schedule, organize, and drive completion of project activities. The Manufacturing Engineer is responsible for supporting manufacturing by developing, qualifying, implementing and maintaining manufacturing equipment, processes and procedures.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
• Assist CTW (cost saving efforts)/continuous improvement initiatives.
• Generate actionable cost savings/continuous improvement ideas.
• Serve as the technical lead for projects.
• Lead technical project execution.
• Develop assembly and test procedures. Create written instructions. Review with document users & update as necessary based on review comments.
• Develop and maintain specifications and procedures for manufacturing, test and inspection processes.
• Develop, create and qualify manufacturing and test equipment.
• Coordinate with divisional and plant functional groups to evaluate and implement changes to products & processes.
• Communicate status of changes to functional groups as well as plant management.
• Evaluate projects
• Develop and maintain specifications and procedures for manufacturing, test and inspection processes.
• Responsible for designing and developing processes to optimize process flow, reduce variability, improve operating capabilities, and ensure operator safety.
• Responsible for creation/update of PFMEA/Risk analysis.
• Identify need for validation of manufacturing equipment/process and support systems to meet product requirements, regulations, quality and company policies.
• Lead the validation/qualification effort for equipment and processes (IQ, OQ & PQ).
• Maintain working knowledge of company policies and procedures, ISO and FDA requirements.
• This job description is not a comprehensive listing of activities, duties or responsibilities that are required of the employee for their job. Duties, responsibilities, and activities may change at any time with or without notice to support the business.

Education and Experience:
• Bachelor’s degree in an engineering discipline.
Preferred: Experience in a manufacturing environment in a regulated industry, medical device.

Knowledge and Skills:
• Experience with troubleshooting electromechanical systems.
• Excellent communication (verbal & written) and interpersonal skills
• Ability to read and understand mechanical drawings and electrical schematics.
• Detail oriented with high level of problem solving and analytical skills
• Familiarity with project management methodologies. Experience with leading technical projects preferred.
• Experience working closely with design engineering, quality engineering and production personnel.
• Familiarity with FDA regulatory requirements, GMP, ISO, lean, process validation and six sigma methodologies.
 

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