Company: International Medical Industries
Location: Pompano Beach
Posted on: November 22, 2021
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
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
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
--- 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
--- Analyze and plan workflow, equipment placement and space
requirements to improve
--- Assures compliance with all regulations and good manufacturing
--- 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
--- Coordinate equipment maintenance and repair services and make
manufacturer's procedures and instructions are followed to keep
--- 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
--- 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.
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
1. Bachelor's Degree or higher in material science,
biomedical, mechanical, or industrial engineering.
2. Proficient in SolidWorks, Minitab, Word, Excel, and
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
8. Experience in automation programming and
9. Six Sigma or Lean Six Sigma green/yellow belt
10. Extensive knowledge of the ISO/FDA requirements for
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.
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
Keywords: International Medical Industries, Pompano Beach , Engineer, Engineering , Pompano Beach, Florida
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