Provides support for automated manufacturing process equipment including process optimization, equipment modification, failure analysis, etc. for the Alere Cholestech LDX product line. Performs validation (IQ, OQ, PQ) of new and existing processes/equipment to improve yield, product performance and/or to introduce new materials. Interfaces with process chemists, manufacturing operators and external equipment suppliers to maintain quality in a high volume medical device manufacturing environment.
Tasks and responsibilities:
· Maintain and improve current automated manufacturing equipment supporting a 24x5 production schedule.
· Attend daily production support meetings and interact with various support teams.
· Investigation and repair of mechanical, pneumatic and electrical systems on manufacturing equipment.
· Coordinate technicians to perform maintenance and repair of automated manufacturing equipment.
· Provide training to manufacturing technicians and operators.
· Write manufacturing work instructions, validation protocols and equipment specifications.
· Perform experiments to aid in the development of improved manufacturing procedures and processes.
· Applies basic understanding of FDA, ISO and GMP theories and principles.
· Works independently on task focused manufacturing projects.
· Contribute to group objectives by completing assignments according to schedule.
· Understands the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
· Carries out duties in compliance with established business policies.
· Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA and other regulatory agencies.
· Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and remains consistent with the company's policies and practices.
· May work with hazardous materials.
· Participate in 5S Lean Activities.
· Perform other duties & projects as assigned.
Preferred educational background:
Bachelor of Science degree in Mechanical Engineering or equivalent experience
Preferred Qualifications:
· Minimum of two years related experience in a manufacturing environment
· Preferred experience in a medical manufacturing environment with custom automated assembly equipment
· Basic knowledge of mechanical design, materials, mechanical, pneumatic and electrical systems, laser printing, ultrasonic welding, micro-fluidic dispensing and plastic injection molding.
· Demonstrate failure analysis and problem-solving skills.
· Typical computer applications include Microsoft Office products, CAD, PLC, statistical analysis, vision inspection, programming and motion control software.
· Experience with validations, technical writing, Six Sigma, 5S, OEE and DOE.
· Able to work in a cross-functional team environment and manage multiple tasks.
· Strong verbal and written communication skills
· Organized and detail oriented
· Basic knowledge of federal and other regulations governing medical device assembly and design, e.g. GMP, QSR, ISO and CMDR.
Alere, Inc. is an equal employment/affirmative action employer of Minorities/Females/Protected Veterans/Disabled. If you need accommodation for any part of the employment process because of a disability please send an email toto let us know the nature of your request
Desired Skills and Experience
Mechanical Engineering and IVD manufacturing required plus knowledge of FDA regulatory requirements.
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