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Engineer

Company: International Medical Industries
Location: Pompano Beach
Posted on: November 22, 2021

Job Description:

Description:
JOB TITLE: Manufacturing Engineer
DEPARTMENT: Manufacturing Engineering
REPORTS TO: Manager, Manufacturing Engineering
FLSA STATUS: Exempt

GENERAL STATEMENT OF DUTIES:
The Manufacturing Engineer will work to drive manufacturing engineering projects to reduce cost,
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. This 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 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 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:
--- 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 manager.
--- 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 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 execute process validation protocols for injection molds and automation
assembly.
--- Prepare and maintain manufacturing work instructions and provide training as required.
--- Performs other manufacturing duties as required.
--- Act as a subject matter expert or a project lead for manufacturing engineering projects.

WORK ENVIRONMENT:
Performs primarily office activities in a lighted and ventilated area. May be subject to changes in
temperature and exposure to dust. Will be exposed to uncontrolled environmental conditions during
driving. Will work in a normally acceptable office environment, production floor, or warehouse, with
no abnormal hazards or risks. Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions
REQUIRED
1. Bachelor's Degree or higher in material science,
biomedical, mechanical, or industrial engineering.
2. Proficient in SolidWorks, Minitab, Word, Excel, and
Project.
3. Minimum of one to two years (1-2) related experience in
an FDA/GMP regulated industry
4. Experience in applying statistical techniques such as
statistical process control, design of experiments, and
problem-solving techniques is required
4. Experience with design, review, execution, and approval
of Installation, Operation and Process Qualification
protocols, and reports (IQ/OQ/PQ)
5. Experience with measuring devices, electromechanical
machinery, and troubleshooting.
6. Experience developing work instructions and training.
PREFERRED BUT NOT REQUIRED
7. Has developed and trained cGMP/GDP to FDA-oversight
companies.
8. Experience in automation programming and
troubleshooting
9. Six Sigma or Lean Six Sigma green/yellow belt
10. Extensive knowledge of the ISO/FDA requirements for
medical devices
11. Master's degree in an Engineering or Science discipline or
equivalent work experience.
12. Experience and competence reading and understanding
drawings, specifications, and performance requirements.
13. Additional class work in management courses, medical
device engineering and problem-solving techniques.
PHYSICAL DEMANDS:
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.**COVID-19 Vaccine Required**PI154487850

Keywords: International Medical Industries, Pompano Beach , Engineer, Engineering , Pompano Beach, Florida

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