Job Title: Manufacturing Engineer
Location: Jacksonville, FL
Duration: 12+Months (Possibility of extension)
JOB ROLE & RESPONSIBILTIES:
This position has the responsibility and authority to support the Manufacturing Engineering group: Develops, refines, maintains and relocate new and existing manufacturing processes, including the creation of manufacturing processing documentation, equipment operating instructions, and product routers.
Designs, constructs and maintains assembly fixtures and test equipment.
Generates, collects and analyses process data, prepares specifications, and evaluates materials and components.
Qualifies and/or validates manufacturing processes and trains production operators.
MAIN JOB DUTIES/RESPONSIBILITIES - ESSENTIAL
Designs, develops, and controls projects associated with the development of new, current, or acquired manufacturing processes.
Participates in new product project team activity, supporting design for manufacturing elements.
Generates, collects and analyses data and prepares specifications, and orders materials and components.
Working understanding of Process Verification and Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.
Provide engineering support for complex medical devices during their development, product launch, and product lifecycle management
Provide technical oversight for manufacturing production performance, including product yield and cycle time management, and driving continuous improvements
Ability to understand product requirements and establish risk-based production controls through data-driven capability analysis, manufacturing control plans, and product acceptance activities
Works with new process development engineering in the evaluation of new processes
Drives a Quality focused culture by monitoring compliance to Quality System processes, such as system transaction compliance, documentation practices, non-conforming material, product holds, Line Clearance, etc.
Designs, constructs, and maintains assembly fixtures and equipment supporting a Lean manufacturing environment.
Ability to understand product requirements and establish risk-based production controls through data-driven capability analysis, manufacturing control plans, and product acceptance activities
Plans and performs a wide variety of technical tasks to develop robust processes and solve non-routine complex manufacturing problems in an effort to maximize consistency, cost effectiveness, and productivity.
Assist in project planning and budgeting.
Collaborates in the design of all special production machinery (jigs, tools, fixtures, machines, and handling equipment) to maintain manufacturing operations at competitive levels
Reviews process yields and tracts defects with the Quality Department against cost of quality
Partners with other departments to ensure that the manufacture and purchase of components meet functional requirements at the lowest possible costs
Limited travel will be required.
Complies with the Healthcare Site Quality System.
Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
Required to interact and communicate with peers and co-workers.
Required to spend extended periods of time on computer-based work.
Performs other duties as assigned.
BASIC QUALIFICATIONS -
Education
Bachelor of Science in Electrical Engineering, Mechanical Engineering or similar relevant discipline required.
Master of Science in Electrical Engineering, Mechanical Engineering or similar relevant discipline preferred
Years of Experience
Minimum of 4 years of experience in a medical device (aerospace or equivalent) manufacturing environment
Skills and Qualifications
Experience in medical product manufacturing/assembly operations is a plus
Demonstrated Project Planning and execution experience on major projects
Green Belt Certification
2 years of Lean Sigma Project Execution experience.
Demonstrated Project Planning and execution experience on major projects.
Kaizen facilitation experience
Strong interpersonal Skills
Experience comprehending quality system process documents
Experience interpreting mechanical drawings
Experience understanding proper documentation/quality requirements for a regulated environment is a plus
Aptitude for quickly learning and as simulating a broad array of information
Excellent data analysis skills, and proficient in the use of statistical tools in problem solving
Understanding of development validation